Data collection schemes for a medical appliance and related methods

ABSTRACT

Embodiments of the present disclosure relate to a monitor device for an ostomy system. The monitor device comprises: a processor; memory; and a first interface connected to the processor and the memory. The first interface comprises a plurality of terminals and a data collector. The plurality of terminals includes a first terminal that forms an electrical connection with a first electrode of an ostomy appliance of the ostomy system and a second terminal that forms an electrical connection with a second electrode of the ostomy appliance. The data collector is coupled to the first and second terminals and comprises a data collection configured to collect data from the plurality of terminals according to a primary data collection scheme and collect data from the plurality of terminals according to a secondary data collection scheme. The primary data collection scheme is different from the secondary data collection scheme.

The present disclosure relates to an ostomy system, devices thereof andmethod for manufacturing an ostomy appliance. The ostomy appliancesystem comprises an ostomy appliance and an ostomy monitor device. Inparticular, the present disclosure relates to data collection schemesfor an ostomy appliance.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8,

FIG. 10 is a distal view of a part of the base plate including monitorinterface,

FIG. 11 illustrates the first interface of the exemplary monitor deviceof the ostomy system, and

FIG. 12 illustrates a flow diagram of a method for data collection froman ostomy appliance.

FIG. 13 is an exemplary graphical representation of parameter data as afunction of time,

FIG. 14 is an exemplary graphical representation of parameter data as afunction of time,

FIG. 15 is an exemplary graphical representation of parameter data as afunction of time,

FIG. 16 is an exemplary graphical representation of parameter data as afunction of time and a whitening zone diameter as a function of time,

FIGS. 17A-17B are exemplary graphical representations of peel force as afunction of a peeling distance travelled by a peeling action exercisingthe peel force on a first adhesive layer of a base plate.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter,with reference to the figures when relevant. It should be noted that thefigures may or may not be drawn to scale and that elements of similarstructures or functions are represented by like reference numeralsthroughout the figures. It should also be noted that the figures areonly intended to facilitate the description of the embodiments. They arenot intended as an exhaustive description of the invention or as alimitation on the scope of the invention. In addition, an illustratedembodiment needs not have all the aspects or advantages shown. An aspector an advantage described in conjunction with a particular embodiment isnot necessarily limited to that embodiment and can be practiced in anyother embodiments even if not so illustrated, or if not so explicitlydescribed.

Throughout this disclosure, the words “stoma” and “ostomy” are used todenote a surgically created opening bypassing the intestines or urinarytract system of a person. The words are used interchangeably, and nodifferentiated meaning is intended. The same applies for any words orphrases derived from these, e.g. “stomal”, “ostomies” etc. Also, thesolid and liquid wastes emanating from the stoma may be referred to asboth stomal “output,” “waste(s),” and “fluids” interchangeably. Asubject having undergone ostomy surgery may be referred to as “ostomist”or “ostomate”—moreover, also as “patient” or “user”. However, in somecases “user” may also relate or refer to a health care professional(HCP), such as a surgeon or an ostomy care nurse or others. In thosecases, it will either be explicitly stated, or be implicit from thecontext that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of alayer, an element, a device or part of a device, the referral is to theskin-facing side or surface when a user wears the ostomy appliance.Likewise, whenever referring to the distal side or surface of a layer,an element, a device or part of a device, the referral is to the side orsurface facing away from the skin when a user wears the ostomyappliance. In other words, the proximal side or surface is the side orsurface closest to the user when the appliance is fitted on a user andthe distal side is the opposite side or surface—the side or surfacefurthest away from the user in use.

The axial direction is defined as the direction of the stoma when a userwears the appliance. Thus, the axial direction is generallyperpendicular to the skin or abdominal surface of the user.

The radial direction is defined as perpendicular to the axial direction.In some sentences, the words “inner” and “outer” may be used. Thesequalifiers should generally be perceived with respect to the radialdirection, such that a reference to an “outer” element means that theelement is farther away from a centre portion of the ostomy appliancethan an element referenced as “inner”. In addition, “innermost” shouldbe interpreted as the portion of a component forming a centre of thecomponent and/or being adjacent to the centre of the component. Inanalogy, “outermost” should be interpreted as a portion of a componentforming an outer edge or outer contour of a component and/or beingadjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features oreffects in this disclosure is intended to simply mean—for a structuralfeature: that a majority or major portion of such feature exhibits thecharacteristic in question, and—for a functional feature or an effect:that a majority of outcomes involving the characteristic provide theeffect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices. Further,methods related to the ostomy system and devices thereof are disclosed.An accessory device (also referred to as an external device) may be amobile phone or other handheld device. An accessory device may be apersonal electronic device, e.g. a wearable, such as a watch or otherwrist-worn electronic device. An accessory device may be a dockingstation. The docking station may be configured to electrically and/ormechanically couple the monitor device to the docking station. Thedocking station may be configured for charging the monitor device and/orconfigured for transferring data between the monitor device and thedocking station. The ostomy system may comprise a server device. Theserver device may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre.

The present disclosure provides an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices whicheither alone or together facilitate reliable determination of thenature, severity and rapidness of moisture propagation in the adhesivematerial provided for attaching the base plate to the skin surface of auser. Depending on the nature of the pattern of moisture propagation inthe adhesive, the ostomy system and devices thereof enable providinginformation to the user about the type of failure, and in turn enableproviding an indication to the user of the severity and thus theremaining time frame for replacing the ostomy appliance withoutexperiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (alsoreferred to as an ostomy bag). The ostomy appliance may be a colostomyappliance, an ileostomy appliance or a urostomy appliance. The ostomyappliance may be a two-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be releasably coupled e.g. with a mechanical and/oran adhesive coupling, e.g. to allow that a plurality of ostomy pouchescan be utilized (exchanged) with one base plate. Further, a two-partostomy appliance may facilitate correct application of the base plate toskin, e.g. to an improved user sight of the stomal region. The ostomyappliance may be a one-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be fixedly attached to each other. The base plateis configured for coupling to a user's stoma and/or skin surrounding thestoma, such as a peristomal skin area.

The base plate comprises a first adhesive layer, also denoted centeradhesive layer. During use, the first adhesive layer adheres to theuser's skin (peristomal area) and/or to additional seals, such assealing paste, sealing tape and/or sealing ring. Thus, the firstadhesive layer may be configured for attachment of the base plate to theskin surface of a user. The first adhesive layer may have a stomalopening with a center point.

The first adhesive layer may be made of a first composition. The firstcomposition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The first composition may comprise one or morehydrocoloids.

The first composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The firstcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the first compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thefirst composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids.

The first composition may comprise 20-60% hydrocolloids. A preferredhydrocolloid is carboxymethyl cellulose (CMC). The first composition mayoptionally contain other components, such as fillers, tackifiers,plasticizers, and other additives.

The first adhesive layer may have a plurality of sensor point openings.A sensor point opening of the first adhesive layer is optionallyconfigured to overlap a part of an electrode, e.g. to form a sensorpoint.

The sensor point openings of the first adhesive layer may compriseprimary sensor point openings. The primary sensor point openings maycomprise one or more primary first sensor point openings and one or moreprimary second sensor point openings, the primary first sensor pointopenings configured to overlap parts of an electrode and the primarysecond sensor point openings configured to overlap parts of anotherelectrode different from the electrode at least partly overlapped by theprimary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisesecondary sensor point openings. The secondary sensor point openings maycomprise one or more secondary first sensor point openings and one ormore secondary second sensor point openings, the secondary first sensorpoint openings configured to overlap parts of an electrode and thesecondary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisetertiary sensor point openings. The tertiary sensor point openings maycomprise one or more tertiary first sensor point openings and one ormore tertiary second sensor point openings, the tertiary first sensorpoint openings configured to overlap parts of an electrode and thetertiary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. Thefirst adhesive layer may have a thickness in the range from 0.1 mm to1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm, such as 0.8 mm or 1.0mm.

The first adhesive layer may have a primary thickness in a primary partof the first adhesive layer, e.g. in a primary region within a primaryradial distance or in a primary radial distance range from the centerpoint of the stomal opening. The primary thickness may be in the rangefrom 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distancemay be in the range from 20 mm to 50 mm, such as in the range from 25 mmto 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondarypart of the first adhesive layer, e.g. in a secondary region outside asecondary radial distance or in a secondary radial distance range fromthe center point of the stomal opening. The secondary thickness may bein the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondaryradial distance may be in the range from 20 mm to 50 mm, such as in therange from 25 mm to 35 mm, e.g. 30 mm.

The base plate may comprise a second layer. The second layer may be anadhesive layer, also denoted rim adhesive layer. The second layer mayhave a second radial extension that is larger than a first radialextension of the first adhesive layer at least in a first angular rangeof the base plate. Accordingly, a part of a proximal surface of thesecond layer may be configured for attachment to the skin surface of auser. The part of a proximal surface of the second layer configured forattachment to the skin surface of a user is also denoted the skinattachment surface of the second adhesive layer. The second layer mayhave a stomal opening with a center point.

The second adhesive layer may be made of a second composition. Thesecond composition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The second composition may comprise one ormore hydrocoloids.

The second composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The secondcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the second compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thesecond composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The secondcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethyl cellulose (CMC). The second composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

Different ratio of contents may change properties of the first and/orsecond adhesive layers. The second adhesive layer and the first adhesivelayer may have different properties. The second adhesive layer (secondcomposition) and the first adhesive layer (first composition) may havedifferent ratios of polyisobutenes, styrene-isoprene-styrene, and/orhydrocoloids. For example, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer. Alternatively or additionally, thesecond adhesive layer may be thinner than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lesswater and/or sweat absorbing than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lessmouldable than the first adhesive layer. The second adhesive layer mayprovide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The secondlayer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. inthe range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate comprises one or more electrodes, such as a plurality ofelectrodes, such as two, three, four, five, six, seven or moreelectrodes. The electrodes, e.g. some or all the electrodes, may bearranged between the first adhesive layer and the second adhesive layer.The electrodes may be arranged in an electrode assembly, e.g. anelectrode layer. An electrode comprises a connection part for connectingthe electrodes to other components and/or interface terminals. Anelectrode may comprise one or more conductor parts and/or one or moresensing parts. The electrode assembly may be arranged between the firstadhesive layer and the second adhesive layer. The base plate, e.g. theelectrode assembly, may comprise a first electrode, a second electrodeand optionally a third electrode. The base plate, e.g. the electrodeassembly, may comprise a fourth electrode and/or a fifth electrode. Thebase plate, e.g. the electrode assembly, optionally comprises a sixthelectrode. The base plate, e.g. the electrode assembly, may comprise aground electrode. The ground electrode may comprise a first electrodepart. The first electrode part of the ground electrode may form a groundfor the first electrode. The ground electrode may comprise a secondelectrode part. The second electrode part of the ground electrode mayform a ground for the second electrode. The ground electrode maycomprise a third electrode part. The third electrode part of the groundelectrode may form a ground for the third electrode. The groundelectrode may comprise a fourth electrode part. The fourth electrodepart of the ground electrode may form a ground for the fourth electrodeand/or the fifth electrode.

The ground electrode or electrode parts of the ground electrode may beconfigured as or form a (common) reference electrode for some or all ofthe other electrodes of the electrode assembly. The ground electrode mayalso be denoted reference electrode.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

The ground electrode may comprise a first electrode part and a secondelectrode part, the first electrode part forming the ground for thefirst electrode and the second electrode part forming the ground for thesecond electrode. The first electrode part may form a closed loop.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

Two electrodes of the electrode assembly may form a sensor. The firstelectrode and the ground electrode (e.g. first electrode part of theground electrode) may form a first sensor or first electrode pair. Thesecond electrode and the ground electrode (e.g. second electrode part ofthe ground electrode) may form a second sensor or second electrode pair.The third electrode and the ground electrode (e.g. third electrode partof the ground electrode) may form a third sensor or third electrodepair. The fourth electrode and the ground electrode (e.g. fourthelectrode part of the ground electrode) may form a fourth sensor orfourth electrode pair. The fifth electrode and the ground electrode(e.g. fifth electrode part of the ground electrode) may form a fifthsensor or fifth electrode pair. The fourth electrode and the fifthelectrode may form a sixth sensor or sixth electrode pair.

An electrode may comprise a sensing part or a plurality of sensingparts, i.e. the part(s) of an electrode that are used for sensing. Thefirst electrode may comprise a first sensing part. The first sensingpart may contact the first adhesive layer and is optionally arranged atleast partly annularly around the stomal opening. The first electrodemay comprise a first conductor part insulated from the first adhesivelayer, e.g. by a masking element arranged between the first conductorpart and the first adhesive layer. The first sensing part may extend atleast 270 degrees around the stomal opening, such as at least 300degrees around the stomal opening. The first sensing part of the firstelectrode may be arranged at a first ground distance from the firstelectrode part of the ground electrode. The first ground distance may beless than 5 mm, such as less than 3 mm, e.g. about 1.0 mm.

The second electrode may comprise a second sensing part. The secondsensing part may contact the first adhesive layer. The second sensingpart may be arranged at least partly annularly around the stomalopening. The second sensing part may extend at least 270 degrees aroundthe stomal opening, such as at least 300 degrees around the stomalopening. The second sensing part of the second electrode may be arrangedat a second ground distance from the second electrode part of the groundelectrode. The second ground distance may be less than 5 mm, such asless than 3 mm, e.g. about 1.0 mm.

The first sensing part may be arranged at a first radial distance fromthe center point and the second sensing part may be arranged at a secondradial distance from the center point. The second radial distance may belarger than the first radial distance. The second electrode may comprisea second conductor part insulated from the first adhesive layer, e.g. bya masking element arranged between the second conductor part and thefirst adhesive layer. The first radial distance may vary as a functionof an angular position with respect to a zero direction from the centerpoint. The second radial distance may vary as a function of an angularposition with respect to a zero direction from the center point. Thezero direction may be defined as the vertical upward direction when thebase plate is in its intended wearing position on an upstanding user.

The first radial distance may be in the range from 5 mm to 40 mm, suchas in the range from 10 mm to 25 mm, e.g. about 14 mm. The second radialdistance may be in the range from 10 mm to 50 mm, such as in the rangefrom 10 mm to 25 mm, e.g. about 18 mm.

The base plate may comprise a third electrode comprising a thirdconnection part. The ground electrode may form a ground for the thirdelectrode. The ground electrode may comprise a third electrode part, thethird electrode part forming the ground for the third electrode. Thethird electrode may comprise a third conductor part insulated from thefirst adhesive layer, e.g. by a masking element arranged between thethird conductor part and the first adhesive layer. The third electrodemay comprise a third sensing part, the third sensing part contacting thefirst adhesive layer. The third sensing part may be arranged at leastpartly annularly around the stomal opening. The third sensing part maybe arranged at a third radial distance from the center point. The thirdradial distance may be larger than the first radial distance and/orlarger than the second radial distance. The third radial distance may bein the range from 15 mm to 50 mm. such as in the range from 20 mm to 30mm, e.g. about 26 mm. The third sensing part may extend at least 270degrees around the stomal opening, such as at least 300 degrees aroundthe stomal opening. The third sensing part of the third electrode may bearranged at a third ground distance from the third electrode part of theground electrode. The third ground distance may be less than 5 mm, suchas less than 3 mm, e.g. about 1.0 mm. A base plate with a groundelectrode, a first electrode, a second electrode, and a third electrodeallow for a failsafe base plate in case e.g. the first electrode is cutor otherwise destroyed during preparation of the base plate.

The base plate may comprise a fourth electrode comprising a fourthconnection part. The ground electrode may form a ground for the fourthelectrode. The ground electrode may comprise a fourth electrode part,the fourth electrode part forming the ground for the fourth electrode.The fourth electrode may comprise one or a plurality of fourth sensingparts, such as at least five fourth sensing parts. The fourth sensingparts may be distributed around the stomal opening or a center pointthereof. The fourth sensing parts may be arranged at respective fourthradial distances from the center point. The fourth radial distance(s)may be larger than the third radial distance. The fourth radialdistance(s) may be in the range from 25 mm to 50 mm, such as about 30mm.

The base plate may comprise a fifth electrode comprising a fifthconnection part. The ground electrode may form a ground for the fifthelectrode. The ground electrode may comprise a fifth electrode part, thefifth electrode part forming the ground for the fifth electrode. Thefifth electrode may comprise one or a plurality of fifth sensing parts,such as at least five fifth sensing parts. The fifth sensing parts maybe distributed around the stomal opening or a center point thereof. Thefifth sensing parts may be arranged at respective fifth radial distancesfrom the center point. The fifth radial distance may be larger than thethird radial distance. The fifth radial distance may be equal to orlarger than the fourth radial distance. The fifth radial distance(s) maybe in the range from 25 mm to 50 mm, such as about 30 mm.

The first electrode may form an open loop. The second electrode may forman open loop, and/or the third electrode may form an open loop. Thefourth electrode may form an open loop. The fifth electrode may form anopen loop. Open loop electrode(s) enables electrode arrangement in fewor a single electrode layer.

The base plate may comprise a second adhesive layer, wherein theplurality of electrodes is arranged between the first adhesive layer andthe second adhesive layer.

The electrode assembly may comprise a support layer, also denoted asupport film. One or more electrodes may be formed, e.g. printed, on theproximal side of the support layer. One or more electrodes may beformed, e.g. printed, on the distal side of the support layer. Theelectrode assembly may have a stomal opening with a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF)and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates, the support layer is made of thermoplasticpolyurethane (TPU). The support layer material may be made of orcomprise one or more of polyester, a thermoplastic elastomer (TPE),polyamide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, andsilicones.

Exemplary thermoplastic elastomers of the support layer are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The electrode assembly/base plate may comprise a masking elementconfigured to insulate at least parts of the electrodes from the firstadhesive layer of the base plate. The masking element may comprise oneor more, such as a plurality of, sensor point openings. The sensor pointopenings may comprise primary sensor point openings and/or secondarysensor point openings. The sensor point openings may comprise tertiarysensor point opening(s). The sensor point openings may comprisequaternary sensor point opening(s) A sensor point opening of the maskingelement overlaps at least one electrode of the electrode assembly whenseen in the axial direction, e.g. to form a sensor point. For example, aprimary sensor point opening may overlap a part of the ground electrodeand/or a part of the fourth electrode. A secondary sensor point openingmay overlap a part of the fourth electrode and/or a part of the fifthelectrode. A tertiary sensor point opening may overlap a part of thefifth electrode and/or a part of the ground electrode.

The masking element may comprise one or more, such as a plurality of,terminal openings. A terminal opening may overlap with one or moreconnection parts of electrodes. In one or more exemplary base plates,each terminal opening overlaps with a single connection part of anelectrode. The masking element may comprise polymeric (e.g.polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica)materials. In one or more exemplary base plates, the masking element ismade of or comprises thermoplastic polyurethane (TPU). In one or moreexemplary base plates, the masking element is made of or comprisespolyester. The masking element material may be made of or comprise oneor more of polyester, a thermoplastic elastomer (TPE), polyamide,polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate may comprise a first intermediate element. The firstintermediate element may be arranged between the electrodes/electrodelayer and the first adhesive layer and/or between the second layer andthe first adhesive layer. The first intermediate layer may be made of aninsulating material.

The base plate may comprise a release liner. The release liner is aprotective layer that protects adhesive layer(s) during transport andstorage and is peeled off by the user prior to applying the base plateon the skin. The release liner may have a stomal opening with a centerpoint.

The base plate may comprise a top layer. The top layer is a protectivelayer protecting the adhesive layer(s) from external strains and stresswhen the user wears the ostomy appliance. The electrodes, e.g. some orall the electrodes, may be arranged between the first adhesive layer andthe top layer. The top layer may have a stomal opening with a centerpoint. The top layer may have a thickness in the range from 0.01 mm to1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, such as 0.04 mm. Thetop layer may have a stomal opening with a center point.

The base plate comprises a monitor interface. The monitor interface maybe configured for electrically and/or mechanically connecting the ostomyappliance (base plate) to the monitor device. The monitor interface maybe configured for wirelessly connecting the ostomy appliance (baseplate) to the monitor device. Thus, the monitor interface of the baseplate is configured to electrically and/or mechanically couple theostomy appliance and the monitor device.

The monitor interface of the base plate may comprise, e.g. as part of afirst connector of the monitor interface, a coupling part for forming amechanical connection, such as a releasable coupling between the monitordevice and the base plate. The coupling part may be configured to engagewith a coupling part of the monitor device for releasably coupling themonitor device to the base plate.

The monitor interface of the base plate may comprise, e.g. as part of afirst connector of the monitor interface, a plurality of terminals, suchas two, three, four, five, six, seven or more terminals, for formingelectrical connections with respective terminals of the monitor device.The monitor interface may comprise a ground terminal element forming aground terminal. The monitor interface may comprise a first terminalelement forming a first terminal, a second terminal element forming asecond terminal and optionally a third terminal element forming a thirdterminal. The monitor interface may comprise a fourth terminal elementforming a fourth terminal and/or a fifth terminal element forming afifth terminal. The monitor interface optionally comprises a sixthterminal element forming a sixth terminal. The terminal elements of themonitor interface may contact respective electrodes of the baseplate/electrode assembly. The first intermediate element may be arrangedbetween the terminal elements and the first adhesive layer. The firstintermediate element may cover or overlap terminal element(s) of thebase plate when seen in the axial direction. Thus, the first adhesivelayer may be protected or experience more evenly distributed mechanicalstress from the terminal elements of the base plate, in turn reducingthe risk of terminal elements penetrating or otherwise damaging thefirst adhesive layer. The first intermediate element may protect ormechanically and/or electrically shield the first adhesive layer fromthe terminal elements of the base plate.

A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal end and a proximalend. A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal part, a centre part,and/or a proximal part. The distal part may be between the distal endand the centre part. The proximal part may be between the proximal endand the centre part. The proximal end/proximal part of a terminalelement may contact a connection part of an electrode. A terminalelement, such as the ground terminal element, the first terminalelement, the second terminal element, the third terminal element, thefourth terminal element, the fifth terminal element and/or the sixthterminal element, may be gold plated copper.

The base plate may comprise a coupling ring or other coupling member forcoupling an ostomy pouch to the base plate (two-part ostomy appliance).The center point may be defined as a center of the coupling ring.

The base plate has a stomal opening with a center point. The size and/orshape of the stomal opening is typically adjusted by the user or nursebefore application of the ostomy appliance to accommodate the user'sstoma. In one or more exemplary base plates, the user forms the stomalopening during preparation of the base plate for application.

A monitor device for an ostomy system comprising an ostomy appliancewith a base plate is disclosed, the monitor device comprising aprocessor configured to apply a processing scheme; memory; a firstinterface connected to the processor and the memory, the first interfaceconfigured for collecting ostomy data from the base plate coupled to thefirst interface, the ostomy data comprising one or more, such as all, offirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, andoptionally third ostomy data from a third electrode pair of the baseplate; and a second interface connected to the processor. To apply aprocessing scheme comprises obtain first parameter data based on thefirst ostomy data; obtain second parameter data based on the secondostomy data; and optionally obtain third parameter data based on thethird ostomy data. To apply a processing scheme comprises determine anoperating state of the base plate of the ostomy appliance. To determinethe operating state of the base plate may be based on one or more, suchas all, of the first parameter data, the second parameter data, thethird parameter data, and fourth parameter data. The operating state maybe indicative of a degree of radial erosion and/or radial swelling ofthe base plate, such as of the first adhesive layer, and/or an acuteleakage risk for the ostomy appliance. The monitor device may beconfigured to transmit a monitor signal comprising monitor dataindicative of the determined operating state of the base plate via thesecond interface. The monitor device may be configured to, in accordancewith a determination that the operating state is a first operatingstate, transmit a first monitor signal comprising monitor dataindicative of the first operating state of the base plate via the secondinterface. The monitor device may be configured to, in accordance with adetermination that the operating state is a second operating state,transmit a second monitor signal comprising monitor data indicative ofthe second operating state of the base plate via the second interface.

An operating state in the present disclosure is indicative of thedynamic internal state of the ostomy appliance (e.g. of the base plateof the ostomy appliance currently being worn by the user) optionallyrelated to adhesive performance of the ostomy appliance. Adhesiveperformance of the ostomy appliance may be related to an internalcondition of the ostomy appliance (e.g. of the base plate of the ostomyappliance), such as an internal condition of an adhesive layer of theostomy appliance. The adhesive performance, and thereby the operatingstate may be affected by several factors, such as humidity, temperature,misplacement of the ostomy appliance on the stoma, and/or malfunction ofthe ostomy appliance. The one or more factors alone or in combinationimpact the adhesive performance of the ostomy appliance. The operatingstate may be varying in time. The operating state may be indicative of adegree of erosion of the base plate.

Adhesive performance may be indicative of wear property, e.g. wear timeand/or wear comfort. The operating state may comprise at least one of: awear time, a quality of adhesion, and a moisture pattern representation.Wear time may comprise average wear time, nominal wear time, minimalwear time, maximal wear time, median wear time, and/or any of otherstatistical metric derivable from wear time. Wear time may compriseremaining wear time and/or current wear time and/or elapsed wear time. Aquality of adhesion may comprise a metric indicative of erosion of alayer of the base plate, such as of the first adhesive layer. A moisturepattern representation may comprise one or more metrics or parametersrepresentative or indicative of a moisture pattern (e.g. a moisturepattern type), e.g. a moisture pattern of the first adhesive layer.

An operating state may be configured to indicate whether the ostomyappliance is properly operational based on its adhesive performance(e.g. wear property, e.g. wear time and/or wear comfort). For example,the operating state may be indicative of the severity and/or imminenceof a leakage (e.g. low, medium, high or acute).

In one or more exemplary monitor devices, the processor is configured toapply a processing scheme, the first interface is connected to theprocessor and the memory, and the first interface is configured forcollecting ostomy data from the base plate coupled to the firstinterface. The ostomy data may comprise one or more, such as all, offirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, and thirdostomy data from a third electrode pair of the base plate. A secondinterface is connected to the processor. To apply a processing schememay comprise one or more of obtain first parameter data based on thefirst ostomy data; obtain second parameter data based on the secondostomy data; and obtain third parameter data based on the third ostomydata. To apply a processing scheme may comprise determine an operatingstate of the base plate of the ostomy appliance based on one or more,such as all, of the first parameter data, the second parameter data andthe third parameter data. The operating state may be indicative of adegree of radial erosion of the base plate, such as of the firstadhesive layer, and/or an acute leakage risk for the ostomy appliance.The monitor device is configured to, in accordance with a determinationthat the operating state is a first operating state, transmit a firstmonitor signal comprising monitor data indicative of the first operatingstate of the base plate via the second interface; and/or in accordancewith a determination that the operating state is a second operatingstate, transmit a second monitor signal comprising monitor dataindicative of the second operating state of the base plate via thesecond interface.

In one or more exemplary monitor devices, the first operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a first degree of radialerosion, e.g. the first adhesive layer is eroded to a first radialdistance of the first electrode pair but not to a second radial distanceof the second electrode pair.

In one or more exemplary monitor devices, the second operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a second degree of radialerosion, e.g. the first adhesive layer is eroded to the second radialdistance of the second electrode pair but not to a third radial distanceof the third electrode pair.

To obtain first parameter data based on the first ostomy data maycomprise determining one or more first parameters based on the firstostomy data. To obtain second parameter data based on the second ostomydata may comprise determining one or more second parameters based on thesecond ostomy data. To obtain third parameter data based on the thirdostomy data may comprise determining one or more third parameters basedon the third ostomy data. In one or more exemplary monitor devices,determination of an operating state may be based on one or more firstparameters, such as first primary parameter and/or first secondaryparameter of first parameter data. In one or more exemplary monitordevices, determination of an operating state may be based on one or moresecond parameters, such as second primary parameter and/or secondsecondary parameter of the second parameter data. In one or moreexemplary monitor devices, determination of an operating state may bebased on one or more third parameters, such as third primary parameterand/or third secondary parameter of the third parameter data. In one ormore exemplary monitor devices, determination of an operating state maybe based on one or more fourth parameters, such as fourth primaryparameter and/or fourth secondary parameter of the fourth parameterdata.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface connected to theprocessor. The first interface may be configured as an applianceinterface for electrically and/or mechanically connecting the monitordevice to the ostomy appliance. Thus, the appliance interface isconfigured to electrically and/or mechanically couple the monitor deviceand the ostomy appliance. The first interface may be configured as anaccessory device interface for electrically and//or mechanicallyconnecting the monitor device to an accessory device, such as a dockingstation. The first interface may be configured for coupling to a dockingstation of the ostomy system, e.g. for charging the monitor deviceand/or for data transfer between the monitor device and the dockingstation.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the base plate. The coupling part and theterminals of the first interface form (at least part of) a firstconnector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensors.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a Bluetooth transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth5. The second interface optionally comprises a loudspeaker and/or ahaptic feedback element for provision of an audio signal and/or hapticfeedback to the user, respectively. The processor may be configured totransmit a monitor signal, such as third monitor signal and/or fourthmonitor signal via the loudspeaker. The processor may be configured totransmit a monitor signal, such as one or more, e.g. all, of firstmonitor signal, second monitor signal, third monitor signal, fourthmonitor signal and default monitor signal, as a wireless monitor signalvia the antenna and the wireless transceiver.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate of the ostomy appliance.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively. The first parameter data, the second parameter data, andthe third parameter data may be indicative of voltage between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively (and thus indicative of resistance). The first parameterdata, the second parameter data, and the third parameter data may beindicative of current between the first electrode pair, the secondelectrode pair, and the third electrode pair, respectively (and thusindicative of resistance).

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of a rate of change in resistancebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively. In one or more exemplary monitordevices, the first parameter data, the second parameter data, and thethird parameter data may be indicative of a rate of change in voltagebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively. In one or more exemplary monitordevices, the first parameter data, the second parameter data, and thethird parameter data may be indicative of a rate of change in currentbetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively.

To determine an operating state of the base plate of the ostomyappliance may comprise to determine an operating state from a set ofoperating states. In other words, to determine an operating state maycomprise selecting an operating state from a set of predefined operatingstates. The set of predefined operating states may comprise a number ofoperating states, such as at least two operating states, at least threeoperating states, at least four operating states, at least fiveoperating states. The number of operating states may be in the rangefrom four to twenty. In one or more exemplary monitor devices, thenumber of operating states in the set of predefined operating states. islarger than ten, such as larger than 20 or even larger than 50.

In one or more exemplary monitor devices, the processor is configured todetermine an operating state of the base plate if a change criterion isfulfilled. The change criterion may be based on the first parameterdata, the second parameter data and/or the third parameter data. Thechange criterion may be fulfilled if parameter data changes, e.g. if achange in parameter data is larger than a change threshold. Thus,operating state determination may be conditional or dependent on achange in the parameter data, in turn leading to an optimum use of poweror battery resources in the monitor device since operating statedetermination is only performed when there may be a change in theoperating state because of the change in parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a first criterion set based on thefirst parameter data and/or the second parameter data, wherein theoperating state is determined to be the first operating state if thefirst criteria set is satisfied. The first criteria set may comprise oneor more first criteria based on one or more of first parameter data,second parameter data and third parameter data. The first criteria setmay comprise a first primary criterion based on the first parameterdata. The first criteria set may comprise a first secondary criterionbased on the second parameter data. The first criteria set may comprisea first tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate may be based on a first threshold set comprisingone or a plurality of first threshold values. The first threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the first criteria set. The first threshold set may comprise a firstprimary threshold value. The first threshold set may comprise a firstsecondary threshold value. The first threshold set may comprise a firsttertiary threshold value.

The first criteria set may be given by or at least may comprise:

-   -   (P_1_1<TH_1_1),    -   (P_2_1>TH_1_2), and    -   (P_3_1>TH_1_3),        wherein P_1_1 is a first primary parameter based on the first        parameter data, TH_1_1 is a first primary threshold value, P_2_1        is a second primary parameter based on the second parameter        data, TH_1_2 is a first secondary threshold value, P_3_1 is a        third primary parameter based on the third parameter data, and        TH_1_3 is a first tertiary threshold value, and wherein the        first operating state is indicative of low degree of radial        erosion on the base plate. The first threshold values (TH_1_1,        TH_1_2 and TH_1_3) may be the same or different, e.g. depending        on the electrode configuration of the base plate. The first        tertiary criterion (P_3_1<TH_1_3) may be omitted in the first        criteria set. The first operating state, e.g. indicative of low        degree of radial erosion on the base plate may be indicative of        a radial progression of moisture to the first electrode pair        (but not to the second electrode pair and not to the third        electrode pair) which corresponds to e.g. an un-alarming and/or        normal radial progression of moisture.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of resistance between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the firstthreshold values (TH_1_1, TH_1_2 and TH_1_3) may correspond to firstresistance threshold values. In one or more exemplary embodiments, thefirst primary threshold value TH_1 _1 may correspond to an upperresistance threshold value. An upper resistance threshold value may beset to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms,such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplaryembodiments, the first secondary threshold value TH_1_2 may correspondto the upper resistance threshold value. In one or more exemplaryembodiments, the first tertiary threshold value TH_1_3 may correspond tothe upper resistance threshold value.

The first primary parameter P_1_1 may be indicative of the resistancebetween the first electrode pair (first electrode and first electrodepart of the ground electrode) of the base plate. The first parameterdata may comprise a first secondary parameter which may be derived fromthe first primary parameter, and/or a first tertiary parameter, whichmay be derived from the first primary parameter. A first secondaryparameter P_1_2 may comprise or be a gradient derived from the firstprimary parameter. In one or more embodiments, a first primary parameterP_1_1 may be indicative of a voltage between the first electrode pair(first electrode and first electrode part of the ground electrode) ofthe base plate.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the firstthreshold values (TH_1_1, TH_1_2 and TH_1_3) may correspond to firstvoltage threshold values. In one or more exemplary embodiments, thefirst primary threshold value TH_1 _1 may correspond to an upper voltagethreshold value. An upper voltage threshold value may be set to a valueless than 5 Volts, such as 3 Volts, such as 2, 86 Volts. In one or moreexemplary embodiments, the first secondary threshold value TH_1 _2 maycorrespond to the upper voltage threshold value. In one or moreexemplary embodiments, the first tertiary threshold value TH-1-3 maycorrespond to the upper voltage threshold value.

The first criteria set may comprise e.g.:

-   -   (P_4_1>TH_1_4)        wherein P_4_1 is a fourth primary parameter based on the fourth        parameter data and indicative of the resistance, voltage, or        current between the fourth electrode pair and TH_1 _4 is a first        quaternary threshold value, and wherein the first operating        state is indicative of absence of fluid on the proximal side of        the first adhesive layer of the base plate of the ostomy        appliance. In one or more exemplary embodiments, the first        quaternary threshold value TH_1_4 may correspond to an upper        resistance threshold value. An upper resistance threshold value        may be set to a value which is less than 30 Mega-Ohms, such as        25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, the following additional criterionmay be determined:

-   -   (P_1 _1<TH_low),        wherein P_1_1 is a first primary parameter based on the first        parameter data, TH_low is a threshold value corresponding to a        lower resistance threshold value. In one or more exemplary        embodiments, a lower resistance threshold value may be set to a        value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80        kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a        saturation of the first electrode pair by the moisture detected        and there are no further changes expected by the first primary        parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, the following additional criterionmay be determined:

-   -   (P_2 _1<TH_low),        wherein P_2_1 is a second primary parameter based on the second        parameter data, TH_low is a threshold value corresponding to a        lower resistance threshold value. In one or more exemplary        embodiments, a lower resistance threshold value may be set to a        value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80        kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a        saturation of the second electrode pair by the moisture detected        and there are no further changes expected by the second primary        parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, the following additional criterionmay be determined:

-   -   (P_3_1>TH_low),        P_3_1 is a third primary parameter based on the third parameter        data, and TH_low is a threshold value corresponding to a lower        resistance threshold value. In one or more exemplary        embodiments, a lower resistance threshold value may be set to a        value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80        kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a        saturation of the third electrode pair by the moisture detected        and there are no further changes expected by the second primary        parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, one or more criteria of a criteriaset, e.g. one or more first criteria of the first criteria set and/orone or more second criteria of the second criteria set, may be based ontiming information or one or more delay parameters based on theparameter data. In one or more exemplary embodiments, one or more delayparameters or time differences related to different parameter data, e.g.related to the first parameter data and the second parameter data, aredetermined.

In one or more exemplary embodiments, one or more first criteria of thefirst criteria set may be based on timing information (e.g. one or moredelay parameters of the parameter data and/or one or more times where aparameter crosses a threshold).

In one or more exemplary embodiments, the timing information maycomprise a time difference D_1_2_1 between a time T1 where P_1_1 crossesa threshold, such as TH_1_1, and a time T2 where P_2_1 crosses athreshold, such as TH_1_2. Thus, delay parameter or time differenceD_1_2_1 may be given as D_1_2_1=T2−T1.

In one or more exemplary embodiments, the timing information, e.g. usedin the first criteria set, may comprise a time difference D_2_3_1between a time T2 where P_2_1 crosses a threshold, such as TH_1_2, and atime T3 where P_3_1 crosses a threshold, such as TH_1_3. Thus, delayparameter or time difference D_2_3_1 may be given as D_2_3_1=T3−T2.

In one or more exemplary embodiments, one or more criteria sets, such asthe third criteria set, and/or the second criteria set, may comprise anyof:

-   -   D_1_2_1>Z    -   D_2_3_1>Z        wherein Z is a time difference constant characterizing the        progression of moisture (e.g. 3 h, e.g. 2 h). Different time        difference constants may be employed in different criteria        sets/for different time delays.

In one or more exemplary embodiments, one or more criteria sets, such asthe second criteria set, and/or the third criteria set may comprise anyof:

-   -   D_1_2_1>Z        wherein Z is a time difference constant characterizing the        progression of moisture (e.g. 3 h, e.g. 2 h).

The second primary parameter may be indicative of the resistance betweenthe second electrode pair (second electrode and second electrode part ofthe ground electrode) of the base plate.

The second parameter data may comprise a second secondary parameter,and/or a second tertiary parameter, which may be derived from the secondprimary parameter. A second secondary parameter may be indicative of avoltage between the second electrode pair (second electrode and secondelectrode part of the ground electrode) of the base plate.

The third primary parameter may be indicative of resistance between thethird electrode pair (third electrode and third electrode part of theground electrode) of the base plate.

The third parameter data may comprise a third secondary parameter,and/or a third tertiary parameter, which may be derived from the thirdprimary parameter. A third secondary parameter may be indicative of avoltage between the second electrode pair (second electrode and secondelectrode part of the ground electrode) of the base plate.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second criterion set based on thesecond parameter data and/or the third parameter data, wherein theoperating state is determined to be the second operating state if thesecond criteria set is satisfied. The second criteria set may be basedon the first parameter data.

The second criteria set may comprise one or more second criteria basedon one or more of first parameter data, second parameter data and thirdparameter data. The second criteria set may comprise a second primarycriterion based on the first parameter data. The second criteria set maycomprise a second secondary criterion based on the second parameterdata. The second criteria set may comprise a second tertiary criterionbased on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second threshold set comprisingone or a plurality of second threshold values. The second threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the second criteria set. The second threshold set may comprise asecond primary threshold value. The second threshold set may comprise asecond secondary threshold value. The second threshold set may comprisea second tertiary threshold value.

The second criteria set may be given by or at least may comprise:

-   -   (P_1_1<TH_2_1),    -   (P_2_1<TH_2_2), and    -   (P_3_1>TH_2_3)        wherein P_1_1 is a first primary parameter based on the first        parameter data and indicative of the resistance between the        first electrode pair, TH_2_1 is a second primary threshold        value, P_2_1 is a second primary parameter based on the second        parameter data and indicative of the resistance between the        second electrode pair, TH_2_2 is a second secondary threshold        value, P_3_1 is a third primary parameter based on the third        parameter data and indicative of the resistance between the        third electrode pair, TH_2_3 is a second tertiary threshold        value, and wherein the second operating state is indicative of        medium degree of radial erosion on the base plate. The second        threshold values (TH_2_1, TH_2_2 and TH_2 _3) may be the same or        different, e.g. depending on the electrode configuration of the        base plate. The second primary criterion (P_1_1<TH_2_1) and/or        the second tertiary criterion (P_3_1>TH_2_3) may be omitted in        the second criteria set.

The second operating state indicative of medium degree of radial erosionon the base plate may be indicative of a radial progression of moistureto the first electrode pair and the second electrode pair (and not thethird electrode pair). The second operating state indicative of mediumdegree of radial erosion on the base plate may be indicative of a radialprogression of moisture to the first electrode pair and to the secondelectrode pair.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of resistance between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the secondthreshold values (TH_2_1, TH_2_2 and TH_2_3) may correspond to secondresistance threshold values. In one or more exemplary embodiments, thesecond primary threshold value TH_2_1 may correspond to an upperresistance threshold value. An upper resistance threshold value may beset to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms,such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplaryembodiments, the second secondary threshold value TH_2_2 may correspondto the upper resistance threshold. In one or more exemplary embodiments,the second tertiary threshold value TH_2_3 may correspond to the upperresistance threshold value. In one or more exemplary embodiments, thesecond primary threshold value TH_2_1 may correspond to a mediumresistance threshold value. A medium resistance threshold value may beset to a value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the secondthreshold values (TH_2_1, TH_2_2 and TH_2_3) may correspond to secondvoltage threshold values. In one or more exemplary embodiments, thesecond primary threshold value TH_2_1 may correspond to an upper voltagethreshold value. An upper voltage threshold value may be set to a valueless than 5 Volts, such as 3 Volts, such as 2.86 Volts. In one or moreexemplary embodiments, the second secondary threshold value TH_2_2 maycorrespond to the upper voltage threshold value. In one or moreexemplary embodiments, the second tertiary threshold value TH_2_3 maycorrespond to the upper voltage threshold value. In one or moreexemplary embodiments, the second primary threshold value TH_2_1 maycorrespond to a medium voltage threshold value. A medium resistancethreshold value may be set to a value less than 10 Mega-Ohms, such as 5Mega-Ohms, such as 3 Mega-Ohms, such as 2 Mega-Ohms, such as 1Mega-Ohms.

In one or more exemplary embodiments, the second criteria set maycomprise any of:

-   -   D_1_2_1>Z        wherein Z is a time difference constant characterizing the        progression of moisture (e.g. 3 h, e.g. 2 h).

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a default criteria set based on thefirst parameter data, wherein the operating state is determined to bethe default operating state if the default criteria set is satisfied,and in accordance with a determination that the operating state is thedefault operating state, transmit a default monitor signal comprisingmonitor data indicative of the default operating state of the ostomyappliance.

The default criteria set may be given by or at least may comprise:

-   -   (P_1_1>TH_D_1),    -   (P_2_1>TH_D_2), and    -   (P_3_1>TH_D_3)        wherein P_1_1 is a first primary parameter based on the first        parameter data and indicative of the resistance between the        first electrode pair, TH_D_1 is a default primary threshold        value, P_2_1 is a second primary parameter based on the second        parameter data and indicative of the resistance between the        second electrode pair, TH_D_2 is a default secondary threshold        value, P_3_1 is a third primary parameter based on the third        parameter data and indicative of the resistance between the        third electrode pair, TH_D_3 is a default tertiary threshold        value, and wherein the default operating state is indicative of        very low or no degree of radial erosion on the base plate. The        default threshold values (TH_D_1, TH_D_2 and TH_D_3) may be the        same or different, e.g. depending on the electrode configuration        of the base plate. In one or more exemplary embodiments, when        the first parameter data, the second parameter data and the        third parameter data are each respectively indicative of        resistance between the first electrode pair, the second        electrode pair and the third electrode pair respectively, the        default threshold values (TH_D_1, TH_D_2 and TH_D_3) may        correspond to default resistance threshold values. In one or        more exemplary embodiments, the second primary threshold value        TH_D_1 may correspond to an upper resistance threshold value. An        upper resistance threshold value may be set to a value which is        less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5        Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplary        embodiments, the default secondary threshold value TH_D_2 may        correspond to the upper resistance threshold. In one or more        exemplary embodiments, the default tertiary threshold value        TH_D_3 may correspond to the upper resistance threshold value.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the defaultthreshold values (TH_D_1, TH_D_2 and TH_D_3) may correspond to defaultvoltage threshold values. In one or more exemplary embodiments, thedefault primary threshold value TH_D_1 may correspond to an uppervoltage threshold value. An upper voltage threshold value may be set toa value less than 5 Volts, such as 3 Volts, such as 2, 86 Volts. In oneor more exemplary embodiments, the default secondary threshold valueTH_D_2 may correspond to the upper voltage threshold value. In one ormore exemplary embodiments, the default tertiary threshold value TH_D_3may correspond to the upper voltage threshold value.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a third criteria set based on thethird parameter data, wherein the operating state is determined to bethe third operating state if the third criteria set is satisfied, and inaccordance with a determination that the operating state is the thirdoperating state, transmit a third monitor signal comprising monitor dataindicative of the third operating state of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a third degree of radialerosion, e.g. the first adhesive layer is eroded to the third radialdistance of the third electrode pair.

The third criteria set may be given by or at least may comprise:

-   -   (P_1_1<TH_3_1),    -   (P_2 _1<TH_3_2), and    -   (P_3_1<TH_3_3)        wherein P_1_1 is a first primary parameter based on the first        parameter data and indicative of the resistance between the        first electrode pair, TH_3_1 is a third primary threshold value,        P_2_1 is a second primary parameter based on the second        parameter data and indicative of the resistance between the        second electrode pair, TH_3_2 is a third secondary threshold        value, P_3_1 is a third primary parameter based on the third        parameter data and indicative of the resistance between the        third electrode pair, TH_3_3 is a third tertiary threshold        value, and wherein the third operating state is indicative of        high degree of radial erosion on the base plate. The third        threshold values (TH_3_1, TH_3_2 and TH_3 _3) may be the same or        different, e.g. depending on the electrode configuration of the        base plate. The third primary criterion (P_1_1<TH_3_1) and/or        the third secondary criterion (P_2_1<TH_3 _2) may be omitted in        the third criteria set. The third operating state indicative of        high degree of radial erosion on the base plate may be        indicative of high likelihood of leakage, e.g. on the proximal        side of the base plate, e.g. within a time period e.g. within        the next 20 minutes. The third operating state may indicate a        radial progression of moisture to the first electrode pair, the        second electrode pair, and the third electrode pair.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of resistance between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the thirdthreshold values (TH_3_1, TH_3_2 and TH_3_3) may correspond to thirdresistance threshold values. In one or more exemplary embodiments, thethird primary threshold value TH_3_1 may correspond to an upperresistance threshold value. In one or more exemplary embodiments, thethird secondary threshold value TH_3_2 may correspond to an upperresistance threshold value. In one or more exemplary embodiments, thethird tertiary threshold value TH_3_3 may correspond to an upperresistance threshold value. An upper resistance threshold value may beset to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms,such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, the third primary threshold valueTH_3_1 may correspond to a lower resistance threshold value. In one ormore exemplary embodiments, a lower resistance threshold value may beset to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80kilo-Ohms, such as 79 kilo-Ohms. In one or more exemplary embodiments,the third secondary threshold value TH_3_2 may correspond to a mediumresistance threshold. A medium resistance threshold value may be set toa value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms. In one or moreexemplary embodiments, the third tertiary threshold value TH_3_3 maycorrespond to the upper resistance threshold. An upper resistancethreshold value may be set to a value which is less than 30 Mega-Ohms,such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the thirdthreshold values (TH_3_1, TH_3_2 and TH_3_3) may correspond to thirdvoltage threshold values. In one or more exemplary embodiments, thethird primary threshold value TH_3_1 may correspond to an upper voltagethreshold value. In one or more exemplary embodiments, the thirdsecondary threshold value TH_3_2 may correspond to an upper voltagethreshold value. In one or more exemplary embodiments, the secondtertiary threshold value TH_2_3 may correspond to the upper voltagethreshold value.

In one or more exemplary embodiments, the third primary threshold valueTH_3_1 may correspond to a lower voltage threshold value. In one or moreexemplary embodiments, a lower voltage threshold value may be set to avalue which is less than 1 Volt, such as 0.5 Volt, such as 0.25 Volts,such as 0.22 Volts. In one or more exemplary embodiments, the thirdsecondary threshold value TH_3_2 may correspond to a medium voltagethreshold value. A medium voltage threshold value may be set to a valueless than 2 Volts, such as 1.5 Volts. In one or more exemplaryembodiments, the second tertiary threshold value TH_2 _3 may correspondto the upper voltage threshold value.

In one or more exemplary embodiments, the third criteria set maycomprise any of:

-   -   D_1_2_1<Z    -   D_2_3_1<Z        Wherein Z is a time difference constant characterizing the        progression of moisture (e.g. 3 h, e.g. 2 h), a time difference        D_1_2_1 between a time T1 where P_1_1 crosses TH_1_1 and a time        T2 where P_2_1 crosses TH_1_2, and a time difference D_2_3_1        between a time T2 where P_2_1 crosses TH_1_2 and a time T3 where        P_3_1 crosses TH_1_3.

In one or more exemplary monitor devices, the ostomy data comprisesfourth ostomy data from a fourth electrode pair of the base plate. Toapply a processing scheme may comprise to obtain fourth parameter databased on the fourth ostomy data and determine an operating state of thebase plate of the ostomy appliance based on the fourth parameter data.The monitor device may be configured to, in accordance with adetermination that the operating state is a fourth operating state,transmit a fourth monitor signal comprising monitor data indicative ofthe fourth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fourth operating state ofthe base plate corresponds to a situation, wherein the fourth electrodepair detects fluid, such as output, between the proximal surface offirst adhesive layer and the skin of the user at a fourth radialdistance, and thus there is a high risk of leakage from the ostomyappliance in the fourth operating state.

The fourth criteria set may be given by or at least may comprise:

-   -   (P_4_1<TH_4_4)        wherein P_4_1 is a fourth primary parameter based on the fourth        parameter data and indicative of the resistance between the        fourth electrode pair and TH_4_4 is a fourth quaternary        threshold value, and wherein the fourth operating state is        indicative of high risk of leakage from the ostomy appliance.

In one or more exemplary embodiments, the fourth quaternary thresholdvalue TH_4_4 may correspond to an upper resistance threshold value.

In one or more exemplary monitor devices, a fifth operating state of thebase plate corresponds to a situation, wherein the fourth electrode pairdetects fluid, such as sweat, between the proximal surface of firstadhesive layer and the skin of the user at a fourth radial distance, andthus there is a no leakage from the ostomy appliance in the fifthoperating state.

The fifth operating state may be determined in accordance with adetermination that one or more fifth criterion of a fifth criteria setare satisfied by fourth parameter data.

The fifth criteria set may be given by or at least may comprise:

-   -   (P_4_1<TH_5_1)    -   (P_4_2<TH_5_2)    -   (P_4_3<TH_5_3)    -   (∇P_4_1<V)    -   (∇P_4_2<V) and    -   (∇P_4_3<V)        wherein P_4_1 is a fourth primary parameter based on the fourth        parameter data and indicative of the resistance between the        fourth electrode pair, P_4_2 is a fourth secondary parameter        based on the fourth parameter data and indicative of the        resistance between the fourth electrode and the fifth electrode,        P_4_3 is a fourth tertiary parameter based on the fourth        parameter data and indicative of the resistance between the        fifth electrode pair and TH_5_1 is a fifth primary threshold        value, TH_5_2 is a fifth secondary threshold value TH_5_3 is a        fifth tertiary threshold value and ∇P_4_1 is gradient of P_4_1,        ∇P_4_2 is gradient of P_4_2, ∇P_4_3 is gradient of P_4_3, and V        is a gradient limit (e.g. 80%). In one or more exemplary        embodiments, the fifth primary threshold value TH_5_1 may        correspond to an upper resistance threshold value. In one or        more exemplary embodiments, TH_5_2 may correspond to an upper        resistance threshold value. n one or more exemplary embodiments,        TH_5_3 may correspond to an upper resistance threshold value. An        upper resistance threshold value may be set to a value which is        less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5        Mega-Ohms, such as 20.4 Mega-Ohms. The fifth operating state may        refer to presence of sweat detected by the fourth parameter data        indicating moisture detected omnidirectionally from the stomal        opening and uniformly.

In one or more exemplary monitor devices, a sixth operating state of thebase plate corresponds to a situation, wherein the fourth electrode pairdetects fluid, such as output, between the proximal surface of firstadhesive layer and the skin of the user at a fourth radial distance, andthus there is a sudden leakage from the ostomy appliance in the sixthoperating state.

The sixth operating state may be determined in accordance with adetermination that one or more sixth criterion of a sixth criteria setare satisfied by the fourth parameter data.

The sixth criteria set may comprise a sixth primary criterion, whereinthe sixth primary criterion may comprise:

-   -   (P_4_1<TH_6_1) and    -   (∇P_4_1>V)

The sixth criteria set may comprise a sixth secondary criterion, whereinthe sixth secondary criterion may comprise:

-   -   (P_4_2<TH_6_2) and    -   (∇P_4_2>V)

The sixth criteria set may comprise a sixth tertiary criterion, whereinthe sixth tertiary criterion may comprise:

-   -   (P_4_3<TH_6_3) and    -   (∇P_4_3>V) wherein P_4_1 is a fourth primary parameter based on        the fourth parameter data and indicative of the resistance        between the fourth electrode pair, P_4_2 is a fourth secondary        parameter indicative of the resistance between the fourth        electrode and the fifth electrode, P_4_3 is a fourth tertiary        parameter indicative of the resistance between the fifth        electrode pair (fifth electrode and ground electrode) and TH_6_1        is a sixth primary threshold value, TH_6_2 is a sixth secondary        threshold value TH_6_3 is a sixth tertiary threshold value, and        ∇P_4_1 is gradient of P_4_1, ∇P_4_2 is gradient of P_4_2, ∇P_4_3        is gradient of P_4_3, and V is a gradient limit (e.g. 80%). In        one or more exemplary embodiments, the sixth primary threshold        value TH_6_1 may correspond to an upper resistance threshold        value. In one or more exemplary embodiments, TH_6_2 may        correspond to an upper resistance threshold value. In one or        more exemplary embodiments, TH_6_3 may correspond to an upper        resistance threshold value. An upper resistance threshold value        may be set to a value which is less than 30 Mega-Ohms, such as        25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.        The sixth operating state may refer to presence of output        detected by the fourth parameter data indicating a sudden leak,        e.g. a developing leak. In one or more exemplary embodiments,        when the time T is below X minutes from the placement of the        base plate, where X is between 5 to 60 minutes, and when any of        P_1_1, P_2_1, P_3_1 in average over T are below a default        threshold value corresponding to an upper resistance threshold        value, this indicates that any of the first electrode pair, the        second electrode pair, and the third electrode pair is cut (e.g.        cut by the user when preparing the base plate for placement        around the stoma). In one or more exemplary embodiments, when        the time T is below X minutes from the placement of the base        plate, where X is between 5 to 60 minutes, and when any of        P_4_1, P_4_2, P_4_3 in average over T are below a default        threshold value corresponding to an upper resistance threshold        value, this indicates an instant leakage, e.g. presence of        output on the proximal side.

In one or more exemplary embodiments, any of the first criteria set, thesecond criteria set, the third criteria set, the fourth criteria set,the default criteria set, the fifth criteria set, the sixth criteria setmay be used to define one or more further criteria sets, and thereby todetermine one or more operating states.

In one or more exemplary embodiments, different criteria sets may beused to determine the same operating state.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface. The first interface maybe configured as an appliance interface for electrically and/ormechanically connecting the monitor device to the ostomy appliance.Thus, the appliance interface is configured to electrically and/ormechanically couple the monitor device and the ostomy appliance. Thefirst interface may be configured as an accessory device interface forelectrically and/or mechanically connecting the monitor device to anaccessory device, such as a docking station. The first interface may beconfigured for coupling to a docking station of the ostomy system, e.g.for charging the monitor device and/or for data transfer between themonitor device and the docking station.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the base plate. The coupling part and theterminals of the first interface form (at least part of) a firstconnector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensor.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a Bluetooth transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth5. The second interface optionally comprises a loudspeaker and/or ahaptic feedback element for provision of an audio signal and/or hapticfeedback to the user, respectively.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate of the ostomy appliance.

The ostomy system may comprise a docking station forming an accessorydevice of the ostomy system. The docking station may be configured toelectrically and/or mechanically couple the monitor device to thedocking station.

The docking station may comprise a docking monitor interface. Thedocking monitor interface may be configured for electrically and/ormechanically connecting the monitor device to the docking station. Thedocking monitor interface may be configured for wirelessly connectingthe monitor device to the docking station. The docking monitor interfaceof the docking station may be configured to electrically and/ormechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, acoupling part for forming a mechanical connection, such as a releasablecoupling between the monitor device and the docking station. Thecoupling part may be configured to engage with a coupling part of themonitor device for releasably coupling the monitor device to the dockingstation.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, aplurality of terminals, such as two, three, four, five, six, seven ormore terminals, for forming electrical connections with respectiveterminals of the monitor device. The docking monitor interface maycomprise a ground terminal. The docking monitor interface may comprise afirst terminal and/or a second terminal. The docking station maycomprise a third terminal. The docking monitor interface may comprise afourth terminal and/or a fifth terminal. The docking monitor interfaceoptionally comprises a sixth terminal.

Disclosed is a monitor device for an ostomy system. The monitor devicecomprises a processor; memory; and a first interface connected to theprocessor and the memory. The first interface comprises: a plurality ofterminals including a first terminal and a second terminal, the firstterminal configured to form an electrical connection with a firstelectrode of an ostomy appliance of the ostomy system and the secondterminal configured to form an electrical connection with a secondelectrode of the ostomy appliance; and a data collector coupled to thefirst terminal and the second terminal. The first electrode and thesecond electrode of the ostomy appliance may indicate differentcharacteristics of the ostomy appliance. For example, the firstelectrode may indicate the quality of adhesion between the ostomyappliance and a skin surface of a user and the second electrode mayindicate the presence or absence of a leak of output between the ostomyappliance and the skin surface of a user. As such, the data received bythe data collector via the first and second terminals may indicatedifferent characteristics of the ostomy appliance.

The data collector comprises a data collection unit and a datacollection controller. The data collection controller is configured to:collect data from the plurality of terminals according to a primary datacollection scheme; and collect data from the plurality of terminalsaccording to a secondary data collection scheme, wherein the primarydata collection scheme is different from the secondary data collectionscheme. In particular, the data collection controller may send one ormore control signals, via a first control pin, to the data collectionunit to collect data according to different data collection schemes(e.g., the primary data collection scheme or the secondary datacollection scheme). The data collected by the data collection unit maybe transmitted from the data collection unit to the data collectioncontroller via first primary and secondary data pins. As stated above,the different terminals may indicate different characteristics of theostomy appliance. As such, it may be beneficial to collect data of thedifferent characteristics according to different data collectionschemes.

In embodiments, the control signal(s) sent to the data collection unitmay be in response to one or more control signals from the processor. Inparticular, the processor may send one or more control signals, via asecond control pin, to the data collection controller and, in response,the data collection controller may send one or more control signals, viathe first control pin, to the data collection unit. In addition, thedata transmitted from the data collection unit to the data collectioncontroller via the first primary and secondary data pins may betransmitted from the data collection controller to the processor via thesecond primary and secondary data pins. The processor may then store thedata collected in memory.

The data collector unit may include one or more analog-to-digitalconverters (ADC). The ADC may receive signals via the terminals andconvert the signals from the analog domain (e.g., voltage) to thedigital domain (e.g., digital signal). In embodiments, the signalacquisition range of the ADC may be controlled by a control signal sentfrom the data collection controller to the data collection unit via thefirst control pin. The signal acquisition range of the ADC may beadapted in response to one or more control signals in order to optimizea signal-to-noise ratio of any signals received via the terminals.Additionally or alternatively, the ADC may be adapted in response towhich of the terminals data is being collected. For example, the ADC maybe adapted in response to which of the first, second, and/or thirdresistive pairs data is being collected.

In embodiments, the sampling rate of the primary data collection schememay be different than a sampling rate of the secondary data collectionscheme. For example, the data collection unit may sample the resistancebetween the first resistive pair, the second resistive pair, the thirdresistive pair, and/or between two sensor points via one or more of theterminals and the sampling rate of the samples may be differentdepending on whether the primary data collection scheme is implementedor the secondary data collection scheme is implemented. That is, thesampling rate of the primary data collection scheme may be at a firstsampling rate and the sampling rate of the secondary collection schememay be at a second sampling rate such that the first sampling rate isdifferent than the second sampling rate. For example, the primary datacollection scheme may include a sampling rate between 0.01 Hz to 0.5 kHzand the secondary data collection scheme may comprise a sampling ratebetween 0.1 Hz to 1.0 kHz. By collecting data at different samplingrates, characteristics of the ostomy appliance that are more likely tochange quickly can be more frequently monitored while characteristicsthat are less likely to change quickly can be less frequently monitored.As such, the longevity of a power unit supplying power to the monitordevice may be increased and/or storage of the memory on which the datacorresponding to the characteristics may be better utilized.

Additionally or alternatively, the primary data collection scheme maydiffer from the secondary data collection scheme by their respectivenumber of samples per measurement. That is, each measurement saved tomemory may be comprised of a number of samples (e.g., the sampledresistance between the first resistive pair, the second resistive pair,the third resistive pair, and/or between two sensor points). And, thenumber of samples per measurement may differ depending on whether theprimary data collection scheme is implemented, or the secondary datacollection scheme is implemented. That is, a measurement of the primarydata collection scheme may include a first number of samples and ameasurement of the secondary data collection scheme may include a secondnumber of samples such that the first number of samples is differentthan the second number of samples. For example, the primary datacollection scheme may comprise ten (10) samples to a measurement and thesecondary data collection scheme may comprise one hundred (100) samplesto a measurement.

Additionally or alternatively, the primary data collection scheme maydiffer from the secondary data collection scheme by their respectivemeasurement rates. In particular, each measurement may be comprised ofone or more samples (e.g., the sampled resistance between the firstresistive pair, the second resistive pair, the third resistive pair,and/or between two sensor points). And, the measurement rates may differdepending on whether the primary data collection scheme is implemented,or the secondary data collection scheme is implemented. That is, themeasurement rate of the primary data collection scheme may be at a firstmeasurement rate and the measurement rate of the secondary collectionscheme may be at a second measurement rate such that the firstmeasurement rate is different than the second measurement rate. Forexample, the primary data collection scheme may include a measurementrate at 50 Hz and the secondary data collection scheme may comprise ameasurement rate at 10 Hz.

The data collection controller may be configured to select the datacollection scheme based on a control signal indicative of the datacollection scheme from the processor. In embodiments, the processor maybe monitoring characteristics of the ostomy appliance, accessory device,user, and/or environment of the user and, based on thesecharacteristics, the processor may instruct the data collectioncontroller to select a specific data collection scheme. Examples ofcharacteristics the processor may be monitoring include but are notlimited to the following.

The processor may be configured to determine the control signal based onan operating state of the ostomy appliance.

The processor may be configured to determine the control signal inaccordance with an orientation of the user.

The processor may be configured to determine the control signal inaccordance with an activity level of a user.

The processor may be configured to determine the control signal inaccordance with a distance between the controller and an accessorydevice.

The processor may be configured to determine the control signal inaccordance with a power capacity of a power unit of the monitor device.

The processor may be configured to determine the control signal inaccordance with a model type of the ostomy appliance.

The processor may be configured to determine the control signal inaccordance with a wear time of the ostomy appliance.

The processor may be configured to determine the control signal inaccordance with preferences of a user of the ostomy appliance.

The processor may be configured to determine the control signal inaccordance with a location of a user of the ostomy appliance.

The processor may be configured to determine the control signal based onif a user cuts, for example, a resistive pair.

The processor may be configured to determine the control signal based onthe wetting of a resistive pair.

Also disclosed is a method for data collection from an ostomy appliance.The method comprises collecting data from a first terminal and a secondterminal according to a primary data collection scheme, the firstterminal forming an electrical connection with a first electrode of anostomy appliance and the second terminal forming an electricalconnection with a second electrode of an ostomy appliance. Similar to asstated above, the different terminals may indicate differentcharacteristics of the ostomy appliance.

The method further comprises collecting data from the first terminal andthe second terminal according to a secondary data collection scheme,wherein the primary data collection scheme is different from thesecondary data collection scheme. Due to the different terminalsindicating different characteristics of the ostomy appliance, it may bebeneficial to collect data of the different characteristics according todifferent data collection schemes.

In embodiments, a sampling rate of the primary data collection schememay be different from a sampling rate of the secondary data collectionscheme. By collecting data at different sampling rates, characteristicsof the ostomy appliance that are more likely to change quickly can bemore frequently monitored while characteristics that are less likely tochange quickly can be less frequently monitored. As such, the longevityof a power unit supplying power to the monitor device may be increasedand/or storage of the memory on which the data corresponding to thecharacteristics may be better utilized.

In embodiments, the method may comprise selecting the data collectionscheme in accordance with an operating state of the ostomy appliance. Inembodiments, characteristics of the ostomy appliance may be monitored(e.g., the operating state of the ostomy appliance) and, based on thesecharacteristics, it may be beneficial to select a specific datacollection scheme based on, potentially different operating states.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1comprises an ostomy appliance 2 including a base plate 4 and an ostomypouch (not shown). Further, the ostomy system 1 comprises a monitordevice 6 and an accessory device 8 (mobile telephone). The monitordevice 6 is connectable to the base plate 4 via respective firstconnectors of the monitor device 6 and base plate 4. The monitor device6 is configured for wireless communication with the accessory device 8.Optionally, the accessory device 8 is configured to communicate with aserver device 10 of the ostomy system 1, e.g. via network 12. The serverdevice 10 may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre. Ostomy data or parameter databased on the ostomy data are obtained from electrodes/sensors of theostomy appliance 2 with the monitor device 6. The monitor device 6processes the ostomy data and/or parameter data based on the ostomy datato determine monitor data that are transmitted to the accessory device8. In the illustrated ostomy system, the accessory device 8 is a mobilephone, however the accessory device 8 may be embodied as anotherhandheld device, such as a tablet device, or a wearable, such as a watchor other wrist-worn electronic device. Accordingly, the monitor device 6is configured to determine and transmit monitor data to the accessorydevice 8. The base plate 4 comprises a coupling member 14 in the form ofa coupling ring 16 for coupling an ostomy pouch (not shown) to the baseplate (two-part ostomy appliance). The base plate 4 has a stomal opening18 with a center point 19. The size and/or shape of the stomal opening18 is typically adjusted by the user or nurse before application of theostomy appliance to accommodate the user's stoma.

The ostomy system 1 optionally comprises a docking station 20 forming anaccessory device of the ostomy system 1. The docking station comprises20 comprises a docking monitor interface including a first connector 22configured for electrically and/or mechanically connecting the monitordevice 6 to the docking station 20. The docking monitor interface may beconfigured for wirelessly connecting the monitor device to the dockingstation. The docking station 20 comprises a user interface 24 forreceiving user input and/or providing feedback to the user on theoperational state of the docking station 20. The user interface 24 maycomprise a touch-screen. The user interface 24 may comprise one or morephysical buttons and/or one or more visual indicators, such as lightemitting diodes.

A user interface refers herein to a graphical representation comprisinga collection of user interface objects. A user interface comprises oneor more user interface objects. A user interface may be referred to as auser interface screen.

A user interface object refers herein to a graphical representation ofan object that is displayed on the display of the accessory device. Theuser interface object may be user-interactive, or selectable by a userinput. For example, an image (e.g., icon), a button, and text (e.g.,hyperlink) each optionally constitute a user interface object. The userinterface object may form part of a widget. A widget may be amini-application that may be used by the user and created by the user. Auser interface object may comprise a prompt, application launch icon,and/or an action menu. An input, such as first input and/or secondinput, may comprise a touch (e.g. a tap, a force touch, a long press), aand/or movement of contact (e.g. a swipe gesture, e.g. for toggling).The movement on contact may be detected by a touch sensitive surface,e.g. on a display of an accessory device. Thus, the display may be atouch sensitive display. An input, such as first input and/or secondinput, may comprise a lift off. An input, such as first input and/orsecond input, may comprise a touch and a movement followed by a liftoff.

The display of the accessory device may be configured to detect touch(e.g. the display is a touch-sensitive display), the input comprises acontact on the touch sensitive display. A touch-sensitive displayprovides an input interface and an output interface between theaccessory device and a user. A processor of the accessory device may beconfigured to receive and/or send electrical signals from/totouch-sensitive display. A touch-sensitive display is configured todisplay visual output to the user. The visual output optionally includesgraphics, text, icons, video, and any combination thereof (collectivelytermed “graphics”). For example, some or all of the visual output may beseen as corresponding to user-interface objects.

The processor of the accessory device may be configured to display, onthe display, one or more user interfaces, such as user interfacescreens, including a first user interface and/or a second userinterface. A user interface may comprise one or more, such as aplurality of user interface objects. For example, the first userinterface may comprise a first primary user interface object and/or afirst secondary user interface object. A second user interface maycomprise a second primary user interface object and/or a secondsecondary user interface object. A user interface object, such as thefirst primary user interface object and/or the second primary userinterface object, may represent an operating state of the base plate.

FIG. 2 is a schematic block diagram of an exemplary monitor device. Themonitor device 6 comprises a monitor device housing 100, a processor 101and one or more interfaces, the one or more interfaces including a firstinterface 102 (appliance interface) and a second interface 104(accessory interface). The monitor device 6 comprises a memory 106 forstoring ostomy data and/or parameter data based on the ostomy data. Thememory 106 is connected to the processor 101 and/or the first interface102.

The first interface 102 is configured as an appliance interface forelectrically and/or mechanically connecting the monitor device 6 to theostomy appliance, e.g. ostomy appliance 2. The first interface 102comprises a plurality of terminals for forming electrical connectionswith respective terminals of the ostomy appliance 2 (base plate 4). Thefirst interface 102 comprises a ground terminal 108, a first terminal110, a second terminal 112 and a third terminal 114. The first interface102 optionally comprises a fourth terminal 116 and a fifth terminal 118.The first interface 102 of the monitor device 6 comprises a couplingpart 120 for forming a mechanical connection, such as a releasablecoupling between the monitor device and the base plate. The couplingpart 120 and the terminals 108, 110, 112, 114, 116, and 118 of the firstinterface 102 form (at least part of) a first connector of the monitordevice 6.

The monitor device 6 comprises a power unit 121 for powering the monitordevice and active components thereof, i.e. the power unit 121 isconnected to the processor 101, the first interface 102, the secondinterface 104, and memory 106. The power unit comprises a battery andcharging circuitry. The charging circuitry is connected to the batteryand terminals of the first interface 102 for charging the battery viaterminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessoryinterface for connecting the monitor device 6 to one or more accessorydevices such as accessory device 8. The second interface 104 comprisesan antenna 122 and a wireless transceiver 124 configured for wirelesscommunication with accessory device(s). Optionally, the second interface104 comprises a loudspeaker 126 and/or a haptic feedback element 128 forprovision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 optionally comprises a sensor unit 140 connected tothe processor 101. The sensor unit 140 comprises a temperature sensorfor feeding temperature data to the processor and/or a G-sensor oraccelerometer for feeding acceleration data to the processor 101.

The processor 101 is configured to apply a processing scheme, and thefirst interface 102 is configured for collecting ostomy data from thebase plate coupled to the first interface, the ostomy data comprisingfirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, and thirdostomy data from a third electrode pair of the base plate. The ostomydata may be stored in the memory 106 and/or processed in the processor101 in order to obtain parameter data. The parameter data may be storedin the memory 106. The processor 101 is configured to apply a processingscheme, wherein to apply a processing scheme comprises obtain firstparameter data based on the first ostomy data; obtain second parameterdata based on the second ostomy data; obtain third parameter data basedon the third ostomy data. In other words, the processor 101 isconfigured to obtain first, second and third parameter data based onrespective first, second and third ostomy data. To apply a processingscheme comprises to determine an operating state of the base plate ofthe ostomy appliance based on one or more, e.g. all, of the firstparameter data, the second parameter data and the third parameter data,wherein the operating state is indicative of a degree of radial erosionof the base plate and/or acute leakage risk for the ostomy appliance.The monitor device 6 is configured to, in accordance with adetermination that the operating state is a first operating state,transmit a first monitor signal comprising monitor data indicative ofthe first operating state of the base plate via the second interface;and in accordance with a determination that the operating state is asecond operating state, transmit a second monitor signal comprisingmonitor data indicative of the second operating state of the base platevia the second interface.

The monitor device 100 is configured to obtain ostomy data from the baseplate coupled to the first interface 102. The ostomy data may be storedin the memory 106 and/or processed in the processor 101 in order toobtain parameter data based on the ostomy data.

FIG. 3 illustrates an exploded view of an exemplary base plate of anostomy appliance. The base plate 4 comprises a first adhesive layer 200with a stomal opening 18A. During use, a proximal surface of the firstadhesive layer 200 adheres to the user's skin in the peristomal areaand/or to additional seals, such as sealing paste, sealing tape and/orsealing ring. The base plate 4 optionally comprises a second adhesivelayer 202, also denoted rim adhesive layer. The base plate 4 comprises aplurality of electrodes arranged in an electrode assembly 204. Theelectrode assembly 204 is arranged between the first adhesive layer 200and the second adhesive layer 202 with a stomal opening 18B. Theelectrode assembly 204 comprises a support layer with stomal opening 18Cand electrodes formed on a proximal surface of the support layer. Thebase plate 4 comprises a release liner 206 that is peeled off by theuser prior to applying the base plate 4 on the skin. The base plate 4comprises a top layer 208 with a stomal opening 18D and a coupling ring209 for coupling an ostomy pouch to the base plate 4. The top layer 208is a protective layer protecting the second adhesive layer 202 fromexternal strains and stress during use.

The base plate 4 comprises a monitor interface. The monitor interface isconfigured for electrically and/or mechanically connecting the ostomyappliance (base plate 4) to the monitor device. The monitor interface ofthe base plate comprises a coupling part 210 for forming a mechanicalconnection, such as a releasable coupling between the monitor device andthe base plate. The coupling part 210 is configured to engage with acoupling part of the monitor device for releasably coupling the monitordevice to the base plate 4. Further, the monitor interface of the baseplate 4 comprises a plurality of terminal elements respectively forminga plurality of terminals 212 for forming electrical connections withrespective terminals of the monitor device. The coupling part 210 andthe terminals 212 form a first connector 211 of the base plate 4. Thebase plate 4 comprises a first intermediate element 213 on the distalside of the electrode assembly. The first intermediate element 213 isarranged between the terminal elements forming terminals 212 and thefirst adhesive layer (not shown). The first intermediate element 213covers the terminal elements forming terminals 212 of the base plate 4when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly204 of a base plate. The electrode assembly 204 has a distal side 204Aand a proximal side 204B. The electrode assembly 204 comprises a supportlayer 214 with proximal surface 214B and electrodes 216 arranged on theproximal side of the support layer 214 and including a ground electrode,a first electrode, a second electrode, a third electrode, a fourthelectrode, and a fifth electrode, wherein each electrode has arespective connection part 217 for connecting the electrodes 216 torespective terminal elements of the monitor interface. The electrodes216 are positioned and/or formed on a proximal side 214B of the supportlayer 214. Further, electrode assembly 204 comprises a masking element218 with proximal surface 218B and configured to insulate electrodeparts of electrodes 216 from the first adhesive layer of the base plate.The masking element 218 covers or overlap with parts of the electrodes216 when seen in the axial direction.

FIG. 5 is a proximal view of proximal surfaces of base plate parts ofthe base plate without the first adhesive layer and the release liner.The base plate 4 comprises a first intermediate element 213 on thedistal side of the electrode assembly, i.e. between the electrodeassembly 204 and the first adhesive layer (not shown). The firstintermediate element 213 covers the terminal elements of the base plate4 when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

FIG. 6 is a distal view of an exemplary electrode configuration 220 ofelectrodes 216 of the electrode assembly 204. The electrodeconfiguration 220/electrode assembly 204 comprises a ground electrode222, a first electrode 224, a second electrode 226, a third electrode228, a fourth electrode 230, and a fifth electrode 232. The groundelectrode 222 comprises a ground connection part 222A and the firstelectrode 224 comprises a first connection part 224A. The secondelectrode 226 comprises a second connection part 226A and the thirdelectrode 228 comprises a third connection part 228A. The fourthelectrode 230 comprises a fourth connection part 230A and the fifthelectrode 232 comprise a fifth connection part 232A.

The fourth electrode 230 comprises fourth sensing parts 230B. The fifthelectrode 232 comprises fifth sensing parts 232B.

The ground electrode 222 comprises a first electrode part 234 forforming a ground or reference for the first electrode 224. The groundelectrode 222 comprises a second electrode part 236 for forming a groundor reference for the second electrode 226. The ground electrode 222comprises a third electrode part 238 for forming a ground or referencefor the third electrode 228. The masking element 218 is arrangedproximal to the electrodes 222, 224, 226, 228 covering and insulatingparts of the electrodes from the first adhesive and forming respectiveconductor parts of the electrodes 222, 224, 226, 228. The parts of theelectrodes 222, 224, 226, 228 not covered by the masking element 219contacts the first adhesive layer and form sensing parts 224B, 226B,228B of electrodes 224, 226, 228, respectively. Further, the electrodeparts 234, 236, 238 form sensing parts of the ground electrode 222.

The first sensing part 224B extends circularly at least 330 degreesaround the stomal opening at a first radial distance R1 from the centerpoint 19. The first radial distance R1 is 14 mm. The first electrodepart 234 is arranged on the inside of the first sensing part (i.e.closer to the center point) and extends circularly at least 330 degreesaround the stomal opening at a first ground distance RG1 from the firstsensing part (radially from the center point). The first ground distanceRG1 between sensing part of first electrode and first electrode part isabout 1 mm.

The second sensing part 226B extends circularly at least 330 degreesaround the stomal opening at a second radial distance R2 from the centerpoint 19. The second radial distance R2 is 18 mm. The second electrodepart 236 is arranged on the inside of the second sensing part 226B (i.e.closer to the center point) and extends circularly at least 330 degreesaround the stomal opening at a second ground distance RG2 from thesecond sensing part 226B (radially from the center point). The secondground distance RG2 between sensing part of second electrode and secondelectrode part is about 1 mm.

The third sensing part 228B extends circularly at least 330 degreesaround the stomal opening at a third radial distance R3 from the centerpoint 19. The third radial distance R3 is about 26 mm. The thirdelectrode part 238 is arranged on the inside of the third sensing part228B (i.e. closer to the center point) and extends circularly at least330 degrees around the stomal opening at a third ground distance RG3from the third sensing part 228B (radially from the center point). Thethird ground distance RG3 between sensing part of third electrode andthird electrode part is about 1 mm.

The ground electrode 222 comprises a fourth electrode part 240 forforming a ground or reference for the fourth electrode 230 and the fifthelectrode 232. The fourth electrode part 240 of the ground electrode 222extends at least 300 degrees around the stomal opening and comprisesground sensing parts 222B. The fourth sensing parts 230B, fifth sensingparts 232B, and ground sensing parts of the fourth electrode part 240are circularly distributed around the center point 19 at a leakageradius from the center point. The fourth sensing parts 230B, fifthsensing parts 232B, and ground sensing parts of the fourth electrodepart may have a radial extension larger than 1.0 mm, such as in therange from 1.5 mm to 3.0 mm, e.g. about 2.0 mm. The fourth sensing parts230B, fifth sensing parts 232B, and ground sensing parts of the fourthelectrode part 240 may have a circumferential extension (perpendicularto the radial extension) larger than 1.0 mm, such as in the range from2.5 mm to 5.0 mm, e.g. about 3.5 mm.

The ground electrode 222 comprises a first electrode part 234 forforming a ground for the first electrode 224. The ground electrode 222comprises a second electrode part 236 for forming a ground for thesecond electrode 226. The ground electrode 222 comprises a thirdelectrode part 238 for forming a ground for the third electrode 228. Theground electrode 222 comprises a fourth electrode part 240 for forming aground for the fourth electrode 230 and the fifth electrode 232. Thefourth electrode part 240 of the ground electrode 222 comprises groundsensing parts 222B.

FIG. 7 is a distal view of an exemplary masking element. The maskingelement 218 optionally has a plurality of terminal openings includingsix terminal openings. The plurality of terminal openings comprises aground terminal opening 242, a first terminal opening 244, a secondterminal opening 246, a third terminal opening 248, a fourth terminalopening 250, and a fifth terminal opening 252. The terminal openings242, 244, 246, 248, 250, 252 of the masking element 218 are configuredto overlap and/or be aligned with respective connection parts 222A,224A, 226A, 228A, 230A, 232A of the electrodes of the electrodeassembly.

The masking element 218 has a plurality of sensor point openings. Thesensor point openings comprise primary sensor point openings shownwithin dotted line 254, each primary sensor point opening configured tooverlap a part of the ground electrode 222 and/or a part of the fourthelectrode 230. The primary sensor point openings 254 comprise, in theillustrated exemplary masking element, five primary first sensor pointopenings 254A each configured to overlap a part of the ground electrode222. The primary sensor point openings 254 comprise, in the illustratedexemplary masking element, four primary second sensor point openings254B each configured to overlap a part of the fourth electrode 230. Thesensor point openings comprise secondary sensor point openings shownwithin dotted line 256, each second sensor point opening configured tooverlap a part of the fourth electrode 230 and/or a part of the fifthelectrode 232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, five secondary first sensor pointopenings 256A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, four secondary second sensorpoint openings 256B each configured to overlap a part of the fourthelectrode 230. The sensor point openings comprise tertiary sensor pointopenings shown within dotted line 258, each tertiary sensor openingconfigured to overlap a part of the fifth electrode 232 and/or a part ofthe ground electrode 222. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, five tertiaryfirst sensor point openings 258A each configured to overlap a part ofthe fifth electrode 232. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, four tertiarysecond sensor point openings 258B each configured to overlap a part ofthe ground electrode 222.

FIG. 8 is a distal view of an exemplary first adhesive layer. The firstadhesive layer 200 has a plurality of sensor point openings. The sensorpoint openings of the first adhesive layer comprise primary sensor pointopenings shown within dotted line 260, each primary sensor point openingconfigured to overlap a part of the ground electrode 222 and/or a partof the fourth electrode 230 of the electrode assembly. The primarysensor point openings 260 comprise, in the illustrated exemplary firstadhesive layer, five primary first sensor point openings 260A eachconfigured to overlap a part of the ground electrode 222. The primarysensor point openings 260 comprise, in the illustrated exemplary firstadhesive layer, four primary second sensor point openings 260B eachconfigured to overlap a part of the fourth electrode 230. The sensorpoint openings of the first adhesive layer comprise secondary sensorpoint openings shown within dotted line 262, each second sensor pointopening configured to overlap a part of the fourth electrode 230 and/ora part of the fifth electrode 232 of the electrode assembly. Thesecondary sensor point openings 262 comprise, in the illustratedexemplary first adhesive layer, five secondary first sensor pointopenings 262A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings 262 comprise, in theillustrated exemplary first adhesive layer, four secondary second sensorpoint openings 262B each configured to overlap a part of the fourthelectrode 230.The sensor point openings of the first adhesive layercomprise tertiary sensor point openings shown within dotted line 264,each tertiary sensor opening configured to overlap a part of the fifthelectrode 232 and/or a part of the ground electrode 222 of the electrodeassembly. The tertiary sensor point openings 264 comprise, in theillustrated exemplary first adhesive layer, five tertiary first sensorpoint openings 264A each configured to overlap a part of the fifthelectrode 232.

The tertiary sensor point openings 264 comprise, in the illustratedexemplary first adhesive layer, four tertiary second sensor pointopenings 264B each configured to overlap a part of the ground electrode222. FIG. 9 is a proximal view of the first adhesive layer of FIG. 8.

FIG. 10 is a more detailed distal view of a part of the base plate 4.Monitor interface of the base plate comprises the first connector 211.The first connector 211 comprises coupling part 210 configured toreleasably couple the monitor device to the base plate and thus forminga releasable coupling. The first connector 211/monitor interfacecomprises a plurality of terminals formed by respective terminalelements for forming respective electrical connections with respectiveterminals of the monitor device.

The plurality of terminals of the first connector 211/monitor interfacecomprises a ground terminal element 282 forming a ground terminal 282A,a first terminal element 284 forming a first terminal 284, a secondterminal element 286 forming a second terminal 286A, and optionally athird terminal element 288 forming a third terminal 288A. The monitorinterface optionally comprises a fourth terminal element 290 forming afourth terminal 290A and/or a fifth terminal element 292 forming a fifthterminal 290. The terminal elements 282, 284, 286, 288, 290, 292 contactrespective connection parts 222A, 224A, 226A, 228A, 230a, 232A ofelectrodes 222, 224, 226, 228, 230, 232.

The position of the first connector on the base plate, the number ofterminals and the position of the terminals in the coupling part may beadapted to the electrode configuration used in the electrode assembly ofthe base plate.

FIG. 11 illustrates the first interface 102 of the exemplary monitordevice 6 of the ostomy system 1. As stated above, the first interface102 is configured as an appliance interface for electrically connectingthe monitor device 6 (illustrated in FIGS. 1 and 2) to the ostomyappliance, e.g., the ostomy appliance 2 (illustrated in FIG. 1). Inembodiments, the first interface 102 may electrically connect the ostomyappliance 2 to the processor 101 and/or memory 106 of the monitor device6.

To electrically connect the monitor device 6 to the ostomy appliance 2,the first interface 102 comprises a ground terminal 108, a firstterminal 110, a second terminal 112, a third terminal 114, a fourthterminal 116, and a fifth terminal 118. Each of the terminals 108, 110,112, 114, 116, 118 connects to a respective electrode of the electrodes216 (illustrated in FIG. 6). In particular, the ground terminal 108 isconfigured to connect to the ground electrode 222 (illustrated in FIG.6) via the ground terminal element 282 (illustrated in FIG. 10), thefirst terminal 110 is configured to connect to the first electrode 224(illustrated in FIG. 6) via the first terminal element 284 (illustratedin FIG. 10), the second terminal 112 is configured to connect to thesecond electrode 226 (illustrated in FIG. 6) via the second terminalelement 286 (illustrated in FIG. 10), the third terminal 114 isconfigured to connect to the third electrode 228 (illustrated in FIG. 6)via the third terminal element 288 (illustrated in FIG. 10), the fourthterminal 116 is configured to connect to the fourth electrode 230(illustrated in FIG. 6) via the fourth terminal element 290 (illustratedin FIG. 10), and the fifth terminal 118 is configured to connect to thefifth electrode 232 (illustrated in FIG. 6) via the fifth terminalelement 292 (illustrated in FIG. 10). Because of these connections, theterminals 108, 110, 112, 114, 116, 118 can respectively receive signalsfrom the ground electrode 222, the first electrode 224, the secondelectrode 226, the third electrode 228, the fourth electrode 230, andthe fifth electrode 232. While the first interface 102 depicts a groundterminal 108, a first terminal 110, a second terminal 112, a thirdterminal 114, a fourth terminal 116, and a fifth terminal 118, the firstinterface 102 may include fewer or more terminals in alternativeembodiments. For example, the first interface 102 may only include aground terminal 108 and a first terminal 110.

As set forth above, the electrodes 222, 224, 226, 228, 230, 232 may havedifferent arrangements on the base plate 4 (illustrated in FIG. 1) ofthe ostomy appliance 2 and/or perform different functions. Due to thesedifferent arrangements and/or functions, the signals from the electrodes222, 224, 226, 228, 230, 232 via the terminals 108, 110, 112, 114, 116,118 may be collected by the first interface 102 and/or stored on thememory 106 according to different data collection schemes 130. Forexample, the processor 101 may access the memory 106 and instruct thefirst interface 102 to collect data from the terminals 108, 110, 112,114, 116, 118 according to a primary data collection scheme 131 and/or asecondary data collection scheme 132. Additionally or alternatively, thedata collection schemes 130 may be collected according to different datacollections schemes 130 (e.g., the primary data collection scheme 131 orthe secondary data collection scheme 132) for other reasons, such as toefficiently allocate the space on the memory 106 and/or based on anoperating state of the ostomy appliance 2, as described in more detailbelow. While the data collection schemes 130 include two data collectionschemes (i.e., the primary data collection scheme 131 and the secondarydata collection scheme 132) in other embodiments, the data collectionschemes 130 includes more than two data collection schemes.

To collect the data, the first interface 102 includes a data collector133. The data collector 133 may comprise a data collection unit 134 anda data collection controller 135.

The data collection controller 135 controls the data collection unit134. In particular, the data collection controller 135 may send one ormore control signals, via a first control pin 136A, to the datacollection unit 134 to collect data according to different datacollection schemes 130 (e.g., the primary data collection scheme 131 orthe secondary data collection scheme 132). The data collected by thedata collection unit 134 may be transmitted from the data collectionunit 134 to the data collection controller 135 via first primary andsecondary data pins 137A, 138A.

In embodiments, the control signal(s) sent to the data collection unit134 may be in response to one or more control signals from the processor101. In particular, the processor 101 may send one or more controlsignals, via a second control pin 136B, to the data collectioncontroller 135 and, in response, the data collection controller 135 maysend one or more control signals, via the first control pin 136A, to thedata collection unit 134. In one or more exemplary monitor devices 5,the data collection controller 135 is connected to the memory 106 andstores the collected data (ostomy data) directly in the memory 106. Inaddition, the data transmitted from the data collection unit 134 to thedata collection controller 135 via the first primary and secondary datapins 137A, 138A may be transmitted from the data collection controller135 to the processor 101 via the second primary and secondary data pins137B, 138B. The processor 101 may then store the data collected inmemory 106.

The data collector unit 134 may include one or more analog-to-digitalconverters (ADC) 139. The ADC 139 may receive signals via the terminals108, 110, 112, 114, 116, 118 and convert the signals from the analogdomain (e.g., voltage) to the digital domain (e.g., digital signal). Inembodiments, the signal acquisition range of the ADC 139 may becontrolled by a control signal sent from the data collection controller135 to the data collection unit 134 via the first control pin 136A. Thesignal acquisition range of the ADC 139 may be adapted in response toone or more control signals to optimize a signal-to-noise ratio of anysignals received via the terminals 108, 110, 112, 114, 116, 118.Additionally or alternatively, the ADC 139 may be adapted in response towhich of the terminals 108, 110, 112, 114, 116, 118 data are beingcollected. For example, the ADC 139 may be adapted in response to whichof the first, second, and/or third resistive pairs 224B, 226B, 228B datais being collected.

Additionally or alternatively, the data collector unit 134 may includeone or more multiplexers 141. In embodiments, the signals received fromthe terminals 108, 110, 112, 114, 116, 118 may be multiplexed by themultiplexer 141 and transmitted to the data collection controller 135.That is, the data collection controller 135 may send a signal to themultiplexer 141 via the first control pin 136A in response to receivinga control signal from the processor 101 via the second control pin 136Bthat indicates from which of the terminals 108, 110, 112, 114, 116, 118data are to be collected. For example, the primary data collection 131scheme may be used for collecting data via a first set of terminals ofthe terminals 108, 110, 112, 114, 116, 118 and the secondary datacollection scheme 132 may be used for collecting data via a second setof terminals of the terminals 108, 110, 112, 114, 116, 118 such that thefirst set of terminals is different from the second set of terminals.For example, the first set of terminals may comprise the terminals 108,110, 112, 114 and the second set of terminals may comprise the terminals108, 116, 118. Due to the first set of terminals comprising theterminals 108, 110, 112, 114, the primary data collection scheme 138 maybe used to collect data of the first resistive pair 224B, the secondresistive pair 226B, and the third resistive pair 228B. Further, due tothe second set of terminals comprising the terminals 108, 116, 118, thesecondary data collection scheme 132 may be used to collect data of thesensor parts 222B, 228B, 230B. While the first set of terminals isdescribed as including 108, 110, 112, 114 and the second set ofterminals is described as including the terminals 108, 116, 118 this isonly an example and not meant to be limiting. After the multiplexer 141receives data from one or more of the terminals 108, 110, 112, 114, 116,118, the data may be transmitted to the data collection controller 135via the first primary and secondary data pins137A, 138A.

In embodiments, the primary data collection scheme 131 may differ fromthe secondary data collection scheme 132 by their respective samplingrates. For example, the data collection unit 134 may sample theresistance between the first resistive pair 224B, the second resistivepair 226B, the third resistive pair 228B, and/or between two sensorpoints via one or more of the terminals 108, 110, 112, 114, 116, 118 andthe sampling rate of the samples may be different depending on whetherthe primary data collection scheme 131 is implemented or the secondarydata collection scheme 132 is implemented. That is, the sampling rate ofthe primary data collection scheme 131 may be at a first sampling rateand the sampling rate of the secondary collection scheme 132 may be at asecond sampling rate such that the first sampling rate is different thanthe second sampling rate. For example, the primary data collectionscheme 131 may include a sampling rate between 0.01 Hz to 0.5 kHz andthe secondary data collection scheme 132 may comprise a sampling ratebetween 0.1 Hz to 1.0 kHz.

Additionally or alternatively, the primary data collection scheme 131may differ from the secondary data collection scheme 132 by theirrespective number of samples per measurement. That is, each measurementsaved to memory 106 may be comprised of a number of samples (e.g., thesampled resistance between the first resistive pair 224B, the secondresistive pair 226B, the third resistive pair 228B, and/or between twosensor points). And, the number of samples per measurement may differdepending on whether the primary data collection scheme 131 isimplemented or the secondary data collection scheme 132 is implemented.That is, a measurement of the primary data collection scheme 131 mayinclude a first number of samples and a measurement of the secondarydata collection scheme 132 may include a second number of samples suchthat the first number of samples is different than the second number ofsamples. For example, the primary data collection scheme 131 maycomprise ten (10) samples to a measurement and the secondary datacollection scheme 132 may comprise one hundred (100) samples to ameasurement.

Additionally or alternatively, the primary data collection scheme 131may differ from the secondary data collection scheme 132 by theirrespective measurement rates. In particular, each measurement may becomprised of one or more samples (e.g., the sampled resistance betweenthe first resistive pair 224B, the second resistive pair 226B, the thirdresistive pair 228B, and/or between two sensor points). And, themeasurement rates may differ depending on whether the primary datacollection scheme 131 is implemented or the secondary data collectionscheme 132 is implemented. That is, the measurement rate of the primarydata collection scheme 131 may be at a first measurement rate and themeasurement rate of the secondary collection scheme 132 may be at asecond measurement rate such that the first measurement rate isdifferent than the second measurement rate. For example, the primarydata collection scheme 131 may include a measurement rate at 1-10minutes and/or the secondary data collection scheme 132 may comprise ameasurement rate at 1-5 minutes.

As stated above, different data collection schemes 130 (e.g., theprimary data collection scheme 131 and/or the secondary data collectionscheme132) may implemented based on an operating state of the ostomyappliance 2. Embodiments of the operating state of the ostomy appliance2 include but are not limited to the following examples.

In embodiments, different data collection schemes 130 (e.g., the primarydata collection scheme 131 and/or the secondary data collectionscheme132) may be implemented based on the orientation of the user. Forexample, if the user is standing up, a data collection scheme 130 (e.g.,the primary data collection scheme 131) may be implemented that isdifferent than the data collection scheme 130 (e.g., the secondary datacollection scheme 132) that is implemented when the user is lying down.The reason being is because the adhesion between the first adhesivelayer 200 and the skin surface of the user will likely degrade at afaster rate due to movement and, perhaps, increased perspiration whenthe user is standing up. As such, a data collection scheme 130 thatcollects data at, for example, a greater sampling rate, a greatermeasurement rate, and/or a greater number of samples per measurement,may be implemented when the user is standing up versus the datacollection scheme 130 that is implemented when the user is lying downto, perhaps, save power consumed by the data collector 133 and/or betterutilize the storage capacity of the memory 106. In embodiments, theorientation of the user may be determined by the sensor unit 140.

In embodiments, different data collection schemes 130 (e.g., the primarydata collection scheme 131 and/or the secondary data collectionscheme132) may be implemented based on the activity level of the user.For example, if the user's activity level is high a data collectionscheme 130 (e.g., the primary data collection scheme 131) may beimplemented that is different than the data collection scheme 130 (e.g.,the secondary data collection scheme 132) that is implemented when theuser is being less active. The reason being is because the adhesionbetween the first adhesive layer 200 and the skin surface of the userwill likely degrade at a faster rate due to movement and, perhaps,increased perspiration when the user's activity level is high. As such,a data collection scheme 130 that collects data at, for example, agreater sampling rate, a greater measurement rate, and/or a greaternumber of samples per measurement, may be implemented when the activitylevel is high versus the data collection scheme 130 that is implementedwhen the activity level is low to, perhaps, save power consumed by thedata collector 133 and/or better utilize the storage capacity of thememory 106. In embodiments, the activity level of the user may bedetermined by the sensor unit 140.

In embodiments, different data collection schemes 130 (e.g., the primarydata collection scheme 131 and/or the secondary data collectionscheme132) may be implemented based on a separation between the monitordevice 6 and an accessory device 8. For example, if signals (e.g.,Bluetooth signals) of the monitor device 6 are out of range of signals(e.g., Bluetooth signals) of the accessory device 8, a data collectionscheme 130 (e.g., the primary data collection scheme 131) may beimplemented that is different than a data collection scheme 130 (e.g.,the secondary data collection scheme 132) that is implemented whensignals of the monitor device 6 are within range of signals of theaccessory device 8. The reason being is because, in embodiments, theaccessory device 8 may provide notifications to the user of the adhesionbetween the first adhesive layer 200 and the skin surface of the userand/or whether output is leaking between the first adhesive layer 200and the skin surface of the user. If the user is unable to receive thesenotifications, then a data collection scheme 130 that collects data at,for example, a lower sampling rate, a lower measurement rate, and/or alower number of samples per measurement, may be implemented when thesignals of the monitor device 6 are out of range of signals of theaccessory device 8 versus the data collection scheme 130 that isimplemented when the signals of the monitor device 6 are within range ofsignals of the accessory device 8 to, perhaps, save power consumed bythe data collector 133 and/or better utilize the storage capacity of thememory 106. In embodiments, the separation between the monitor device 6and the accessory device 8 may be determined by the second interface104.

In embodiments, different data collection schemes 130 (e.g., the primarydata collection scheme 131 and/or the secondary data collectionscheme132) may be implemented based on the power capacity of the powerunit 121. For example, if the power capacity of the power unit 121 isbelow a threshold then a data collection scheme 130 (e.g., the primarydata collection scheme 131) may be implemented that is different thanthe data collection scheme 130 (e.g., the secondary data collectionscheme 132) that is implemented when the power capacity of the powerunit 121 is above a threshold. The reason being is because, inembodiments, the power unit 121 may be more likely to run out of powerand, therefore, be unable to provide indications of the quality ofadhesion between the first adhesive layer 200 and the skin surface ofthe user and/or whether output is leaking between the first adhesivelayer 200 and the skin surface of the user. As such, a data collectionscheme 130 that collects data at, for example, a lower sampling rate, alower measurement rate, and/or a lower number of samples permeasurement, may be implemented when the power capacity of the powerunit 121 is below a threshold versus the data collection scheme 130 thatis implemented when the power capacity of the power unit 121 is above athreshold to, perhaps, save power of the power unit 121. In embodiments,the power capacity of the power unit 121 may be determined by theprocessor 101.

In embodiments, different data collection schemes 130 (e.g., the primarydata collection scheme 131 and/or the secondary data collectionscheme132) may be implemented based on the model type of the ostomyappliance 2. For example, some models of an ostomy appliance 2 may havebetter or worse adhesion between the first adhesive layer 200 and theskin surface of the user. As such, a data collection scheme 130 thatcollects data at, for example, a higher sampling rate, a highermeasurement rate, and/or a higher number of samples per measurement, maybe implemented when the ostomy appliance 2 is a first model type havingworst adhesion versus the data collection scheme 130 that is implementedwhen the ostomy appliance 2 is a second model type having betteradhesion to, perhaps, allow timely detection of a leak. In embodiments,the model type of the ostomy appliance 2 may be input into the processor101, sensed by the sensor unit 140, and/or the like.

In embodiments, different data collection schemes 130 (e.g., the primarydata collection scheme 131 and/or the secondary data collectionscheme132) may be implemented be based on the wear time of the ostomyappliance 2. For example, a data collection scheme 130 that collectsdata at, for example, a higher sampling rate, a higher measurement rate,and/or a higher number of samples per measurement, may be implementedwhen the user has been wearing the ostomy appliance 2 for a period oftime that exceeds a threshold versus the data collection scheme 130 thatis implemented when the user has been wearing the ostomy appliance 2 fora period of time that doesn't exceed the threshold. An advantage ofcollecting data at a higher sampling rate, a higher measurement rate,and/or a higher number of samples per measurement when the wear time isgreater than a threshold is because the adhesion between the firstadhesive layer 200 and the skin surface of the user will likely degradeover time and, therefore, the likelihood of a leak increases. Inembodiments, the processor 101 may determine whether the wear time hassurpassed the threshold. Additionally or alternatively, the thresholdmay be input into the monitor device 6 and/or based on a previous weartime of the ostomy appliance 2 by the user.

In embodiments, different data collection schemes 130 (e.g., the primarydata collection scheme 131 and/or the secondary data collectionscheme132) may be implemented based on a user's preferences. Forexample, when the user has a preference that he/she would like to knowwithin a threshold period of time that the adhesion between the firstadhesive layer 200 and the skin surface of the user degrades below athreshold amount, a specific data collection 130 scheme may beimplemented to allow the user to be notified within said thresholdperiod. Basing the data collection scheme 130 on a user's preference mayprovide piece of mind for the user.

In embodiments, different data collection schemes 130 (e.g., the primarydata collection scheme 131 and/or the secondary data collectionscheme132) may be implemented based on the location of the user. Forexample, users of ostomy appliances 2 may differ in their ostomy habitsbased on the location of the users. For example, users in a firstcountry may change their ostomy appliances 2 more frequently than usersin a second country due to, perhaps, better healthcare subsidies. Assuch, users in the first country may wish to have quicker notificationsof adhesion degradation than users in the second country. Accordingly, adata collection scheme 130 that collects data at, for example, a highersampling rate, a higher measurement rate, and/or a higher number ofsamples per measurement, may be implemented when the ostomy appliance 2is being used in a first location versus the data collection scheme 130that is implemented when the ostomy appliance 2 is being used in asecond location to, perhaps, allow quicker notifications about adhesiondegradation.

In embodiments, different data collection schemes 130 (e.g., the primarydata collection scheme 131 and/or the secondary data collectionscheme132) may be implemented based on if a user cuts, for example, aresistive pair (e.g., the first, second, and/or third resistive pairs224B, 226B, 228B) when configuring the stomal opening 18. For example, adata collection scheme 130 that collects data at, for example, a lowersampling rate, a lower measurement rate, and/or a lower number ofsamples per measurement, may be implemented for a cut resistive pairversus a data collection scheme 130 that is implemented on a non-cutresistive pair to, perhaps, save power consumed by the data collector133 and/or better utilize the storage capacity of the memory 106.

In embodiments, different data collection schemes 130 (e.g., the primarydata collection scheme 131 and/or the secondary data collectionscheme132) may be implemented based on the wetting of a resistive pair(e.g., the first, second, and/or third resistive pairs 224B, 226B,228B). For example, a data collection scheme 130 that collects data at,for example, a lower sampling rate, a lower measurement rate, and/or alower number of samples per measurement may be implemented for a wetresistive pair versus a data collection scheme 130 that is implementedon a non-wet resistive pair to, perhaps, save power consumed by the datacollector 133 and/or better utilize the storage capacity of the memory106.

FIG. 12 illustrates a flow diagram of a method 300 for data collectionfrom an ostomy appliance. To facilitate describing method 300, referenceis made to the other figures, in particular, FIGS. 1, 2, 6, and 11.

In embodiments, the method 300 comprises collecting data from a firstterminal and a second terminal according to a primary data collectionscheme 131 (block 302). In embodiments, the data may be collected by thedata collector 133 and the first terminal and the second terminal may beone or more of the terminals 108, 110, 112, 114, 116, 118. Because ofthese connections, the terminals 108, 110, 112, 114, 116, 118 canrespectively receive signals from the ground electrode 222, the firstelectrode 224, the second electrode 226, the third electrode 228, thefourth electrode 230, and the fifth electrode 232.

The method 300 further comprises collecting data from the first terminaland the second terminal according to a secondary data collection scheme132 (block 304). In embodiments, the primary data collection scheme 131is different from the secondary data collection scheme 132. For example,the sampling frequency of the primary data collection scheme 131 may bedifferent than the sampling frequency of the secondary data collectionscheme 132. Additionally or alternatively, the number of samples permeasurement of the primary data collection scheme 131 may be differentthan the number of samples of the secondary data collection scheme 132.Additionally or alternatively, the measurement frequency of the primarydata collection scheme 131 may be different than the measurementfrequency of the secondary data collection scheme 132.

In embodiments, the method 300 further comprises selecting the datacollection scheme 130 in accordance with an operating state of theostomy appliance 2 (block 306). In embodiments, the operating state ofthe ostomy appliance 2 may be sent by the processor 101 to the datacollector 133 via a control signal. Examples of the operating state ofthe ostomy appliance 2 include, but are not limited to, the orientationof the user, the activity level of the user, whether signals of themonitor device 102 are within signals of the accessory device 8, thepower capacity of the power unit 121, the model type of the ostomyappliance 2, the wear time of the ostomy appliance 2, user preferences,and/or a location of the user of the ostomy appliance 2.

The position of the first connector on the base plate, the number ofterminals and the position of the terminals in the coupling part may beadapted to the electrode configuration used in the electrode assembly ofthe base plate.

FIG. 14 shows an exemplary graphical representation of parameter data asa function of time. In this example, the parameter data in the y-axis isin Volts and time is in the x-axis. Curve 1100 shows, as a function oftime, a first parameter data indicative of voltage measured by the firstelectrode pair of the base plate. Curve 1102 shows, as a function oftime, a second parameter data indicative of voltage measured by thesecond electrode pair of the base plate. Curve 1104 shows, as a functionof time, a third parameter data indicative of voltage measured by thethird electrode pair of the base plate.- Curves 1108, 1116, 1118 show,as a function of time, fourth primary parameter indicative of voltagemeasured by the fourth electrode pair of the base plate, fourthsecondary parameter indicative of voltage measured by the fourthelectrode and the fifth electrode of the base plate, and fourth tertiaryparameter indicative of voltage measured by the fifth electrode pair ofthe base plate respectively. Curves 1110, 1112, 1114 show, as a functionof time, a gradient of fourth primary parameter indicative of voltagegradient measured by the fourth electrode pair of the base plate, agradient of fourth secondary parameter indicative of voltage gradientmeasured by the fourth electrode and the fifth electrode of the baseplate, and a gradient of fourth tertiary parameter indicative of voltagegradient measured by the fifth electrode pair of the base platerespectively. FIG. 14 shows the upper voltage threshold valuerepresented as curve 1000, the medium voltage threshold valuerepresented as curve 1002, the lower voltage threshold value representedas curve 1004, and curve 1006 is a gradient limit.

Curves 1108, 1116, 1118 as well as curves 1110, 1112, 1114 show that nomoisture is detected at the proximal side of the first adhesive layer bythe fourth electrode pair.

At a time less than 5h, curve 1100 shows that moisture is detected bythe first electrode pair as the first parameter data crosses the uppervoltage threshold value while curve 1102 shows that moisture is notdetected by the second electrode pair as the second parameter data hasnot crossed the upper voltage threshold value. At this stage, it isdetermined that the ostomy appliance is in a first operating state.

At time between 5 h and 10 h, curve 1102 shows that moisture is detectedby the second electrode pair as the second parameter data crosses theupper voltage threshold value. At this stage, it is determined that theostomy appliance is in a second operating state.

At time around 45 h, curve 1104 shows that moisture is detected by thethird electrode pair as the third parameter data crosses the uppervoltage threshold value. At this stage, it is determined that the ostomyappliance is in a third operating state.

FIG. 15 shows an exemplary graphical representation of parameter data asa function of time. In this example, the parameter data in the y-axis isin Volts and time is in the x-axis.

Curve 1202 shows, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate. Curve 1204 shows, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate. Curve 1200 shows, as a function of time, a third parameter dataindicative of voltage measured by the third electrode pair of the baseplate. Curves 1206, 1208, 1210 show, as a function of time, fourthprimary parameter indicative of voltage measured by the fourth electrodepair of the base plate, fourth secondary parameter indicative of voltagemeasured by the fourth electrode and the fifth electrode of the baseplate, and fourth tertiary parameter indicative of voltage measured bythe fifth electrode pair of the base plate respectively. Curves 1212,1214, 1216 show, as a function of time, a gradient of fourth primaryparameter indicative of voltage gradient measured by the fourthelectrode pair of the base plate, a gradient of fourth secondaryparameter indicative of voltage gradient measured by the fourthelectrode and the fifth electrode of the base plate, and a gradient offourth tertiary parameter indicative of voltage gradient measured by thefifth electrode pair of the base plate respectively. FIG. 26 shows theupper voltage threshold value represented as curve 1000, the mediumvoltage threshold value represented as curve 1002, the lower voltagethreshold value represented as curve 1004, and curve 1006 represents agradient limit.

Curves 1206, 1208, 1210 as well as curves 1212, 1214, 1216 show thatmoisture is detected at the proximal side of the first adhesive layer bythe fourth electrode pair, the fourth and fifth electrode, and the fifthelectrode pair at a time starting at 60 h until 90 h. As the threeelectrode pairs are triggered as shown by the decreases shown by 1206,1208, 1210 and as the curves 1212, 1214, 1216 show a gradient below 80%,this is indicative of the presence of sweat at the proximal side of thefirst adhesive layer.

At a time of 30 min, curve 1202 shows that moisture is detected by thefirst electrode pair as the first parameter data crosses the uppervoltage threshold value while curve 1204 shows that moisture is notdetected by the second electrode pair as the second parameter data hasnot crossed the upper voltage threshold value. At this stage, it isdetermined that the ostomy appliance is in a first operating state.

At time around 40 h, curve 1204 shows that moisture is detected by thesecond electrode pair as the second parameter data crosses the uppervoltage threshold value. At this stage, it is determined that the ostomyappliance is in a second operating state.

FIG. 16 shows an exemplary graphical representation of parameter data asa function of time. In this example, the parameter data in the y-axis isin Volts and time is in the x-axis. Curve 1300 shows, as a function oftime, a first parameter data indicative of voltage measured by the firstelectrode pair of the base plate. Curve 1302 shows, as a function oftime, a second parameter data indicative of voltage measured by thesecond electrode pair of the base plate. Curve 1304 shows, as a functionof time, a third parameter data indicative of voltage measured by thethird electrode pair of the base plate. Curves 1306, 1308, 1310 show, asa function of time, fourth primary parameter indicative of voltagemeasured by the fourth electrode pair of the base plate, fourthsecondary parameter indicative of voltage measured by the fourthelectrode and the fifth electrode of the base plate, and fourth tertiaryparameter indicative of voltage measured by the fifth electrode pair ofthe base plate respectively. Curves 1312, 1314, 1316 show, as a functionof time, a gradient of fourth primary parameter indicative of voltagegradient measured by the fourth electrode pair of the base plate, agradient of fourth secondary parameter indicative of voltage gradientmeasured by the fourth electrode and the fifth electrode of the baseplate, and a gradient of fourth tertiary parameter indicative of voltagegradient measured by the fifth electrode pair of the base platerespectively. FIG. 16 shows the upper voltage threshold valuerepresented as curve 1000, the medium voltage threshold valuerepresented as curve 1002, the lower voltage threshold value representedas curve 1004, and curve 1006 is a gradient limit.

Curves 1306, 1308, 1310 as well as curves 1312, 1314, 1316 show thatmoisture is detected at the proximal side of the first adhesive layer bythe fourth electrode pair at a time starting at around 25h. As leakageelectrodes (i.e. the fourth electrode pair, the fourth and fifthelectrode, and the fifth electrode pair) are trigger as shown by thedecreases shown by 1306, 1308, 1310 and as curve 1312, 1314, 1316 show agradient above 80%, this is indicative of the presence of output at theproximal side of the first adhesive layer. This indicate severe leakage.It may be determined that the ostomy appliance is in a sixth operatingstate.

At a time of 5 h, curve 1300 shows that moisture is detected by thefirst electrode pair as the first parameter data crosses the uppervoltage threshold value while curve 1302 shows that moisture is notdetected by the second electrode pair as the second parameter data hasnot crossed the upper voltage threshold value. At this stage, it isdetermined that the ostomy appliance is in a first operating state.

At time around 15 h, curve 1302 shows that moisture is detected by thesecond electrode pair as the second parameter data crosses the uppervoltage threshold value. At this stage, it is determined that the ostomyappliance is in a second operating state.

At time around 30 h, curve 1304 shows that moisture is detected by thethird electrode pair as the third parameter data crosses the uppervoltage threshold value. In an example where the curves 1306, 1308, 1310had not dropped below corresponding thresholds, curve 1304 indicatesthat moisture has reached the third electrode pair, and the presentdisclosure enables determining that the ostomy appliance is in a thirdoperating state.

FIG. 17 shows an exemplary graphical representation of parameter data asa function of time and a whitening zone diameter (e.g. related to aradial thickness of a whitening ring surrounding the stomal opening) asa function of time. FIG. 17 illustrates the moisture propagation in thefirst adhesive layer as a function of time and illustrates a correlationbetween parameter data detected by the first electrode pair and thesecond electrode pair of the base plate and actual moisture on theproximal surface of the first adhesive layer of the base plate. Theactual moisture propagation in the first adhesive layer may appear as awhitening zone (e.g. a white ring around the stomal opening) in thefirst adhesive layer. Moisture affects the first adhesive layer in thatthe moisture reacts with the composition of the first adhesive layer toform the white ring around the stomal opening, and thereby reducesadhesive performance of the base plate. FIG. 17 is obtained byexperiments where water is applied from the stomal opening of the basedplate to follow, using the electrodes of the base plate, the radialpropagation of moisture leading to radial erosion of the first adhesivelayer of the base plate.

Curve 1502 shows, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate. Curve 1504 shows, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate. Curve 1506 shows a diameter of the white ring as a function oftime. The first parameter data shows a decrease in e.g. voltage measuredby the first electrode pair over time. It is also seen that the voltageof the second electrode pair drops at a later time than when the firstparameter data shows a decrease in e.g. voltage dropped. This correlateswell with the diameter of the white ring which goes from around 25-26 mmwhen the first electrode pair is triggered (e.g. first parameter datashows a decrease) to 38 mm when the second electrode pair is triggered(second parameter data shows a decrease). This corresponds substantiallyto the location of the first electrode pair at twice the first radialdistance R1, and of the second electrode pair at twice the second radialdistance R2.

It is noted that various regions and countries have various routines andrecommendations to support optimal use of an ostomy appliance. Forexample, in regions of Europe, it may be indicated to the user that anostomy appliance with a base plate as disclosed herein is an optimalstate (corresponding to a first operating state) when the radialthickness of the whitening ring is between 0-15 mm (for a user not incompliance with a preferred use), such as between 0-7 mm (for a user incompliance with a preferred use), such as between 0-5 mm (recommended bya nurse).

For example, in Europe, it may be indicated to the user that an ostomyappliance with a base plate as disclosed herein is in suboptimal state(corresponding to a second operating state) and thereby indicate aconsideration to change the base plate when the radial thickness of thewhitening ring is such as between 5-10 mm (recommended by a nurse),between 7 mm and 10 mm (for a user in compliance with a preferred use),and/or between 15 mm and 30 mm (for a user not in compliance with apreferred use).

For example, in Europe, it may be indicated to the user that an ostomyappliance with a base plate as disclosed herein is in a poor state(corresponding to a third operating state) and indicate a request tochange the base plate when the radial thickness of the whitening ring ismore than 10 mm (recommended by a nurse), such as more than 15 mm (for auser in compliance with a preferred use), such as more than 30 mm (for auser not in compliance with a preferred use).

For example, in other regions (e.g. America), it may be indicated to theuser that an ostomy appliance with a base plate as disclosed herein isan optimal state (corresponding to a first operating state) when theradial thickness of the whitening ring is between 0-20 mm (for a usernot in compliance with a preferred use), such as between 0-10 mm (for auser in compliance with a preferred use), such as between 0-10 mm(recommended by a nurse).

For example, in other regions (e.g. America), it may be indicated to theuser that an ostomy appliance with a base plate as disclosed herein isin suboptimal state (corresponding to a second operating state) andthereby indicate a consideration to change the base plate when theradial thickness of the whitening ring is such as between 10 mm and 20mm (recommended by a nurse), between 10 mm and 20 (for a user incompliance with a preferred use), and/or between 20 mm and 40 mm (for auser not in compliance with a preferred use).

For example, in other regions (e.g. America), it may be indicated to theuser that an ostomy appliance with a base plate as disclosed herein isin a poor state (corresponding to a third operating state) and indicatea request to change the base plate when the radial thickness of thewhitening ring is more than 20 mm (recommended by a nurse), such as morethan 20 mm (for a user in compliance with a preferred use), such as morethan 40 mm (for a user not in compliance with a preferred use).

The disclosed methods, ostomy appliances, monitor devices, and accessorydevices allow to accommodate the regional preferences of user in theiruse of the ostomy appliance to adjust thresholds for the operatingstates to the regional preference or use.

FIGS. 18A-18B shows exemplary graphical representations of peel force asa function of a peeling distance travelled by a peeling actionexercising the peel force (e.g. perpendicularly to the proximal (ordistal) surface of the first adhesive layer) on a first adhesive layerof a base plate disclosed herein. The peel force relates to a requiredforce to peel the first adhesive layer off the skin surface. The peelingdistance is with respect to one end of the first adhesive layer wherethe peel force starts to be exercised. The peeling distance relates tothe size or length of the first adhesive layer and thereby may relate toa size or length of a portion the first adhesive layer affected bymoisture and of a portion of the first adhesive layer not affected bymoisture. The peel forces illustrated in FIGS. 18A-18B arerepresentative of adhesive performance of the first adhesive layer ofthe base plate to the skin surface.

Composition of the first adhesive layer of the base plate as disclosedherein in one or more embodiments is formulated to provide adhesion ofthe base plate to the skin surface of the user when the base plate isworn and to maintain a dry and healthy skin surface. Avoiding macerationof skin when occluding the skin with an adhesive is done by transportingsweat away from the skin and into the first adhesive layer by means ofe.g. hydrocolloid types and adhesive (e.g. hydrocolloid adhesives)forming part of an absorbing element of the first adhesive layer.

For example, when the absorbing element is in contact with moisture,(e.g. water, sweat, urine or feces), the absorbing element absorb themoisture. This reduces the adhesion of the first adhesive layer to theskin.

For example, the first adhesive layer goes from a dry adhesive statewith acceptable adhesive performance (e.g. acceptable adhesion andcohesion) in to a wet adhesive state (e.g. reduced or non-adhesion andlow cohesion gel).

Curve 1602 of FIGS. 18A and 18B shows a peel force applied to the firstadhesive layer as a function of a peeling distance travelled by apeeling action exercising the peel force on the first adhesive layer ina dry adhesive state, (e.g. not affected by moisture). The peel force isexpressed in Newtons while the peeling distance is expressed in mm. Thelength of the first adhesive layer in dry adhesive state is illustratedby X5, corresponding to length of the first adhesive layer 1608 in dryadhesive state.

Curve 1602 shows that the peel force applied to the first adhesive layerin a dry adhesive state is equal to Y1 when the peeling distance is lessthan X1. At X1, the peeling force drops as the peeling distanceincreases towards X5 and the end of the first adhesive layer.

Curve 1604 of FIG. 18A shows a peel force applied to the first adhesivelayer as a function of a peeling distance travelled by a peeling actionexercising the peel force on the first adhesive layer in a wet adhesivestate, (e.g. affected by moisture to the point of reaching a completelywet adhesive state, where the first adhesive layer has become a gel).

Curve 1604 shows that when the peeling distance is less than X2, thepeel force applied to the first adhesive layer in a wet adhesive stateis equal to Y2 which has much lower value than Y1. This shows that theadhesive performance of the first adhesive layer is reduced when thefirst adhesive layer is in a wet adhesive state. At X2, the peelingforce drops as the peeling distance increases until the end of the firstadhesive layer. It is noted that X2 is larger than X1, because the firstadhesive layer in a wet adhesive state extends in volume, and thus inlength due to the gelling of the components of the first adhesive layer.

The peel experiment illustrated in FIG. 18A shows a loss of adhesiveperformance when the first adhesive is in a wet adhesive state.

Curve 1606 of FIG. 18B shows a peel force applied to the first adhesivelayer as a function of a peeling distance travelled by a peeling actionexercising the peel force on the first adhesive layer illustrated 1610which comprises a first portion 1610A in a dry adhesive state and asecond portion 1610B in a wet adhesive state, (e.g. affected by moistureto the point of reaching a completely wet adhesive state, where thefirst adhesive layer has become a gel).

Curve 1606 shows that when the peeling distance is less than X3, thepeel force applied to the first adhesive layer in a wet adhesive stateis equal to Y3 which has lower value than Y1. This shows that theadhesive performance of the first adhesive layer is reduced when thefirst adhesive layer comprises a portion in a wet adhesive state. At X3,the peeling force drops as the peeling distance increases until the endof the first adhesive layer. It is noted that X3 corresponds to thelength of the portion 1610A in dry adhesive state.

The peel experiment illustrated in FIG. 18B shows a loss of adhesiveperformance when the first adhesive is partly in a wet adhesive state.

Accordingly, FIG. 18A-18B demonstrate that the operating statedetermined based on monitor data is indicative of adhesive performanceof the base plate.

The use of the terms “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. does not imply any particular order but areincluded to identify individual elements. Moreover, the use of the terms“first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. does not denote any order or importance, but rather theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. are used to distinguish one element from another. Notethat the words “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. are used here and elsewhere for labellingpurposes only and are not intended to denote any specific spatial ortemporal ordering. Furthermore, the labelling of a first element doesnot imply the presence of a second element and vice versa.

Although particular features have been shown and described, it will beunderstood that they are not intended to limit the claimed invention,and it will be made obvious to those skilled in the art that variouschanges and modifications may be made without departing from the spiritand scope of the claimed invention. The specification and drawings are,accordingly to be regarded in an illustrative rather than restrictivesense. The claimed invention is intended to cover all alternatives,modifications and equivalents.

LIST OF REFERENCES

1 ostomy system

2 ostomy appliance

4 base plate

6 monitor device

8 accessory device

10 server device

12 network

14 coupling member

16 coupling ring

18, 18A, 18B, 18C, 18D stomal opening

19 center point

20 docking station

22 first connector

24 user interface

100 monitor device housing

101 processor

102 first interface

104 second interface

106 memory

108 ground terminal of monitor device

110 first terminal of monitor device

112 second terminal of monitor device

114 third terminal of monitor device

116 fourth terminal of monitor device

118 fifth terminal of monitor device

120 coupling part

121 power unit

122 antenna

124 wireless transceiver

126 loudspeaker

128 haptic feedback element

130 data collection schemes

131 primary data collection scheme

132 secondary data collection scheme

133 data collector

134 data collection unit

135 data collection controller

136A first control pin

136B second control pin

137A first primary data pin

137B second primary data pin

138A first secondary data pin

138B second secondary data pin

138 primary data collection scheme

139 analog-to-digital converter

140 sensor unit

141 multiplexer

200 first adhesive layer

200A distal surface of first adhesive layer

200B proximal surface of first adhesive layer

202 second adhesive layer

202A distal surface of second adhesive layer

202B proximal surface of second adhesive layer

204 electrode assembly

204A distal surface of electrode assembly

204B proximal surface of electrode assembly

206 release liner

206A distal surface of the release liner

206B proximal surface of the release liner

208 top layer

208A distal surface of the top layer

208B proximal surface of the top layer

209 coupling ring

210 coupling part of first connector

211 first connector

212 terminals of first connector

213 first intermediate element

213A distal surface of first intermediate element

213B proximal surface of first intermediate element

214 support layer of electrode assembly

214A distal surface of support layer

214B proximal surface of support layer

216 electrodes of electrode assembly

217 connection parts of electrodes

218, 219 masking element

218A distal surface of masking element

218B proximal surface of masking element

220, 220A, 220B electrode configuration

222 ground electrode

222A ground connection part

222B ground sensing part

224 first electrode

224A first connection part

224B first sensing part

226 second electrode

226A second connection part

226B second sensing part

228 third electrode

228A third connection part

228B third sensing part

230 fourth electrode

230A fourth connection part

230B fourth sensing part

232 fifth electrode

232A fifth connection part

232B fifth sensing part

234 first electrode part of the ground electrode

236 second electrode part of the ground electrode

238 third electrode part of the ground electrode

240 fourth electrode part of the ground electrode

242 ground terminal opening

244 first terminal opening

246 second terminal opening

248 third terminal opening

250 fourth terminal opening

252 fifth terminal opening

254 primary sensor point openings of masking element

254A primary first sensor point opening

254B primary second sensor point opening

256 secondary sensor point openings of masking element

256A secondary first sensor point opening

256B secondary second sensor point opening

258 tertiary sensor point openings of masking element

258A tertiary first sensor point opening

258B tertiary second sensor point opening

260 primary sensor point openings of first adhesive layer

260A primary first sensor point opening

260B primary second sensor point opening

262 secondary sensor point openings of first adhesive layer

262A secondary first sensor point opening

262B secondary second sensor point opening

264 tertiary sensor point openings of first adhesive layer

264A tertiary first sensor point opening

264B tertiary second sensor point opening

282 ground terminal element

282A ground terminal

284 first terminal element

284A first terminal

286 second terminal element

286A second terminal

288 third terminal element

288A third terminal

290 fourth terminal element

290A fourth terminal

292 fifth terminal element

292A fifth terminal

300 method of data collection from an ostomy appliance

302 collecting data according to a primary data collection scheme

304 collecting data according to a secondary data collection scheme

306 selecting the data collection scheme

1100 curve showing, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate

1102 curve showing, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate

1104 curve showing, as a function of time, a third parameter dataindicative of voltage measured by the third electrode pair of the baseplate

1108 curve showing, as a function of time, a fourth primary parameterindicative of voltage measured by the fourth electrode pair of the baseplate

1110 curve showing, as a function of time, a gradient of fourth primaryparameter indicative of voltage gradient

1112 curve showing, as a function of time, a gradient of fourthsecondary parameter indicative of voltage gradient measured

1114 curve showing, as a function of time, a gradient of fourth tertiaryparameter indicative of voltage gradient measured

1116 curve showing, as a function of time, a fourth secondary parameterindicative of voltage measured

1118 curve showing, as a function of time, a fourth tertiary parameterindicative of voltage measured

1200 curve showing, as a function of time, a third parameter dataindicative of voltage measured by the third electrode pair of the baseplate

1202 curve showing, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate

1204 curve showing, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate

1206 curve showing, as a function of time, a fourth primary parameterindicative of voltage measured by the fourth electrode pair of the baseplate

1208 curve showing, as a function of time, a fourth secondary parameterindicative of voltage measured

1210 curve showing, as a function of time, a fourth tertiary parameterindicative of voltage measured

1212 curve showing, as a function of time, a gradient of fourth primaryparameter indicative of voltage gradient measured by the fourthelectrode pair of the base plate

1214 curve showing, as a function of time, a gradient of fourthsecondary parameter data indicative of voltage gradient measured

1216 curve showing, as a function of time, a gradient of fourth tertiaryparameter indicative of voltage gradient measured

1300 curve showing, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate

1302 curve showing, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate

1304 curve showing, as a function of time, a third parameter dataindicative of voltage measured by the third electrode pair of the baseplate

1306 curve showing, as a function of time, a fourth primary parameterindicative of voltage measured by the fourth electrode pair of the baseplate

1308 curve showing, as a function of time, a fourth secondary parameterindicative of voltage measured

1310 curve showing, as a function of time, a fourth tertiary parameterindicative of voltage measured

1312 curve showing, as a function of time, a gradient of fourth primaryparameter indicative of voltage gradient measured by the fourthelectrode pair of the base plate

1314 curve showing, as a function of time, a gradient of fourthsecondary parameter indicative of voltage gradient measured

1316 curve showing, as a function of time, a gradient of fourth tertiaryparameter indicative of voltage gradient measured

1502 curve showing, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate

1504 curve showing, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate

1506 curve showing a diameter of the white ring as a function of time

1602 curve showing peel force applied to the first adhesive layer in adry adhesive state as a function of peeling distance

1604 a peel force applied to the first adhesive layer as a function of apeeling distance travelled by a peeling action exercising the peel forceon the first adhesive layer in a wet adhesive state

1606 a peel force applied to the first adhesive layer as a function of apeeling distance travelled by a peeling action exercising the peel forceon the first adhesive layer partially wet

1608 length of the first adhesive layer 1608 in dry adhesive state

1610 the first adhesive layer which comprises a first portion in a dryadhesive state and a second portion in a wet adhesive state

1610A a first portion in a dry adhesive state

1610B a second portion in a wet adhesive state

1. A monitor device for system, the monitor device comprising: aprocessor; memory; and a first interface connected to the processor andthe memory, the first interface comprising: a plurality of terminalsincluding a first terminal and a second terminal, the first terminalconfigured to form an electrical connection with a first electrode of amedical appliance of the medical system and the second terminalconfigured to form an electrical connection with a second electrode ofthe appliance, and a data collector coupled to the first terminal andthe second terminal and configured to: collect data from said first andsecond terminals according to a data collection scheme selected from aprimary data collection scheme and a secondary data collection scheme,the primary data collection scheme being different from the secondarydata collection scheme, the data collector comprising a data collectioncontroller configured to select the data collection scheme based on acontrol signal indicative of the data collection scheme from theprocessor.
 2. The monitor device of claim 1, wherein a sampling rate ofthe primary data collection scheme is different than a sampling rate ofthe secondary data collection scheme.
 3. The monitor device of claim 1,wherein the processor is configured to determine the control signalbased on an operating state of the medical appliance.
 4. The monitordevice of claim 1, wherein the processor is configured to determine thecontrol signal in accordance with an orientation of the user.
 5. Themonitor device of claim 1, wherein the processor is configured todetermine the control signal in accordance with an activity level of auser.
 6. The monitor device of claim 1, wherein the processor isconfigured to determine the control signal in accordance with a distancebetween the controller and an accessory device.
 7. The monitor device ofclaim 1, wherein the processor is configured to determine the controlsignal in accordance with a power capacity of a power unit of themonitor device.
 8. The monitor device of claim 1, wherein the processoris configured to determine the control signal in accordance with a modeltype of the medical appliance.
 9. The monitor device of claim 1, whereinthe processor is configured to determine the control signal inaccordance with a wear time of the medical appliance.
 10. The monitordevice of claim 1, wherein the processor is configured to determine thecontrol signal in accordance with preferences of a user of the medicalappliance.
 11. The monitor device of claim 1, wherein the processor isconfigured to determine the control signal in accordance with a locationof a user of the medical appliance.
 12. A method for data collectionfrom an medical appliance, the method comprising: selecting a datacollection scheme from a primary data collection scheme and a secondarydata collecting scheme, the primary data collection scheme beingdifferent from the secondary data collection scheme, in accordance withan operating state of the medical appliance, in accordance withselecting the primary data collection scheme; collecting data from afirst terminal and a second terminal according to the primary datacollection scheme, the first terminal forming an electrical connectionwith a first electrode of the medical appliance and the second terminalforming an electrical connection with a second electrode of the medicalappliance; and in accordance with selecting the secondary datacollection scheme; collecting data from the first terminal and thesecond terminal according to the secondary data collection scheme. 13.The method of claim 12, wherein a sampling rate of the primary datacollection scheme is different from a sampling of the secondary datacollection scheme.
 14. The method of claim 12, the method comprisingselecting the data collection scheme in accordance with an operatingstate of the medical appliance.